CN106974688A

CN106974688A - Surgical incision and closure equipment

Info

Publication number: CN106974688A
Application number: CN201710111840.9A
Authority: CN
Inventors: 埃米尔·贝尔森; 埃里克·斯托内; 艾伦·斯卡赫尔; 潘卡杰·瑞斯; 柳庆郎; 一柳庆一郎; 彼得·达奎尼; 卢克·克劳森
Original assignee: Qi Pulin Pharmaceuticals
Current assignee: Qi Pulin Pharmaceuticals; Zipline Medical Inc
Priority date: 2012-10-31
Filing date: 2013-10-30
Publication date: 2017-07-25
Anticipated expiration: 2033-10-30
Also published as: CN106974688B; AU2013337891B2; JP2021090813A; EP2914183A1; JP7301081B2; CN104755033B; EP2914183A4; WO2014070922A1; CN104755033A; JP6240205B2; EP3574848A1; EP2914183B1; JP2019150628A; AU2013337891A1; JP2017205583A; KR20150058533A; JP6842496B2; JP6527560B2; KR101611144B1; JP2016503313A

Abstract

A kind of equipment for closing surgical incision, the equipment includes left substrate and right substrate, multiple closing assemblies and coupled to multiple left axial supports of corresponding substrate and right axial support.Left substrate and right substrate are laterally coupled together by closing assembly, and with the left-end point coupled to corresponding substrate and right end.Closing assembly is across left plate and right panel located lateral, left axial support is placed between paired left closing assembly end, right axial support is placed between paired right closing assembly end, and left axial support and right axial support are offset from one another, so as to form the snakelike arrangement of continuous closing assembly and axial support.The equipment by antimicrobial material or can be impregnated with the material of antimicrobial and be made.When deployed, flexible adhesive covering can be provided on the device.

Description

Surgical incision and closure equipment

The application be submit within 04 13rd, 2015, entitled " surgical incision and closure equipment ", Application No. (international application no is PCT/US2013/067563 to 201380053449.8 Chinese patent application, and international filing date is 2013 October 30) divisional application.

The cross reference of related application

This application claims (the attorney of U.S. Patent Application No. 13/665,160 submitted on October 31st, 2012 Priority 35383-709.501), it is (the agency of U.S. Patent Application No. 13/286,757 submitted on November 1st, 2011 People file number 35383-709.201), and the U.S. Provisional Patent Application No. 61/958,259 submitted on July 24th, 2013 (attorney 35383-710.101), and the U.S. Provisional Patent Application No. 61/ submitted on October 11st, 2013 889,569 (attorney 35383-712.101) continuation-in-part application, the complete disclosure of above-mentioned application passes through It is incorporated by this.

Background of invention

1. invention field.Present invention relates in general to Medical Devices and method.More particularly the invention relate to shape Into the apparatus and method with closure surgical incision.

It is known including the surgical closure device with right panel and the binding agent based paster of left plate.Institute of the invention is special Such device not interested is described in co-pending, jointly owned PCT application US 2010/000430, this application it is complete Portion's disclosure is incorporated by reference into this.As described in the PCT application, surgical incision is desirably formed on patient skin Place bioadhesive patch in position.After paster is placed, along the axis formation otch extended through in the middle part of paster.Cut in formation After mouthful, otch can be opened to carry out desired operation technique, and after operation technique completion, can by using clip, The inward flange of the plate is pulled together and close incisions by slide fastener or other enclosed members.

The main target of such surgical closure device is the cicatrization for improving healing and reduction caused by otch.However, This target is but hindered by some characteristics of currently available device.For example, organization edge is not always equal along a line Gather together evenly, this may increase final cicatrization.Many such closing devices are without in regulation organization edge Closing force or closing distance ability, thus limit and have been observed that can reduce cicatrization makes what tissue somewhat " wrinkled " Ability.It can include being difficult with the other shortcomings of otch and Wound closure devices, and the nothing during follow-up operation plan Method is adapted to tissue manipulation, i.e. sufficiently rigid device often can not be in surgical operation for securely closing tissue for those It is adapted to tissue movement in operating process.

Particular problem occurs when it is used for below adhesion surgical incision drop cloth in self-adhering type wound closure paster.It is such Drop cloth is used for the aseptic that tissue surface is assisted in keeping in surgical procedure, and can be placed on drop cloth previously On the tissue closure paster of positioning.Because surgical incision drop cloth has the adhesion lower surface for adhering to tissue, therefore drop cloth will Adhere to the upper surface of following tissue closure paster.Surgical incision drop cloth removal thus often remove previously placed group Knit closure paster or at least shift it.If tissue closure paster any pith be removed or shift, paster for Close surgical wound just there is no with.

For these reasons, expect to provide improved surgical incision closing device and its application method.It is particularly desired in providing Such Tncision closing device：It can adhere to tissue, allow otch formation, adapted in subsequent surgical operation operating process In the deformation of tissue, and provide after operation technique the controlled closure at adjacent tissue edge.Specifically, it is expected that otch is closed While attaching together the least commitment or stretching put and tissue is caused in surgical procedure, using the teaching of the invention it is possible to provide in organization edge Closing force control and be uniformly distributed.It is also expected to providing such improved surgical incision closing device and its application method： Removal will be wherein resisted when the device is used below surgical incision drop cloth and is dislocated.Invention described below will be real At least some targets in these existing targets.

2. background technology is described.In U.S. Patent number 2,012,755；3,516,409；3,863,640；3,933,158；4, 114,624；3,926,193；4,535,772；4,676,245；4,881,546；4,905,694；5,377,695 and 7,455, 681；And describe surgical closure device in U.S. Patent Publication No. 2005/0020956 and 2008/0114396.Common The U.S. Patent number 8,313,508,8,323,313 and 8,439,945 possessed；U.S. Patent Publication No. 2013/0066365；With And described in PCT Publication WO 2011/139912, WO 2011/159623, WO 2011/043786 and WO 2013/067024 Further surgical closure device, the full content of above-mentioned document is incorporated by reference into this.Commercial Tncision closing device can Bought from Johnson＆Johnson Ethicon departments, its trade name Ethizip^TMInterim abdominal wound closing device.

The content of the invention

It is used to close wound the invention provides improved apparatus and method, especially enters in surgical procedure Wound caused by capable incision.Otch will generally be formed on the skin of the patient, such as through belly, but in some feelings In condition, it is also possible on internal organs, in oral cavity, in body cavity, etc..

Apparatus and method of the present invention will be present to be upset to making the minimum of the surgical procedures carried out after otch Or interference.Particularly, described device and method will allow to cut with the least commitment caused by the presence as closing device Tissue opposite edges open, stretching and Free Transform.Once however, operation technique completion, apparatus and method of the present invention It will provide for being uniformly distributed closing force, so as to be pulled together organization edge in the way of causing cicatrization to minimize. Particularly, the spacing that the spacing that initially there are when the closing device can be to form than otch is slightly moved closer to is by organization edge It is pulled together, so as to " corrugation " that organization edge is turned up upwards and cause that cicatrization can be reduced.

Apparatus and method of the present invention will also be able to avoid or reduce when cut closure apparatus is used for surgical incision drop cloth Upset during lower section, the surgical incision drop cloth must be moved up from closure apparatus and removed.At least one in the upper surface of closure apparatus Divide upper offer sacrifice layer, wherein when surgical incision drop cloth is placed on cut closure apparatus, sacrificing covering and being kept just Position.After otch and surgical procedures are completed, it will left behind surgical incision drop cloth from the skin of patient.Surgical drape is adhered to To covering is sacrificed, rather than adhere to tissue closure apparatus and it is dislocated, and only sacrifice covering with drop cloth from trouble Left behind with person, and the remainder for leaving cut closure apparatus keeps in situ.

In the first aspect of the present invention, cut closure apparatus includes base portion, and the base portion includes left plate and right panel.Each plate With tissue adhension lower surface, upper surface, inward flange and outward flange.Undertissue's adhesive surface generally will be at least in part Conventional tissue adhension adhesive is coated with, those adhesives such as used in surgical bandage and paster.

Also including the power distributed architecture coupled to each plate, (that is, each plate will have coupled thereto cut closure apparatus At least one power distributed architecture), wherein each power distributed architecture is adapted to allow for the plate axially expanding along inward flange, together When limitation lateral magnification over the entire length and axially expanded along outer peripheral.By allowing the plate along inward flange Axially expand, organization edge is deformed when being stretched by minimum constraint with allowing to be organized in surgical procedure.Phase Instead, by limiting lateral magnification and being axially expanded along outer peripheral, the plate will can complete it in surgical procedures Apply controlled and distribution closing force when the plate is pulled together afterwards, as described in more detail below.

Cut closure apparatus also includes closing assembly or assembly, and the closing assembly or assembly are attached to power distributed architecture By the plate after having been completed with the tissue and surgical procedures of the opposite sides that cutting part has been adhered in the plate Inward flange be pulled together.Each plate of base portion will generally include flexible matrix at least in part, generally with it is each to Same sex elasticity (that is, plate is evenly stretched in all directions), but alternatively there is anisotropic elasticity (wherein described matrix Preferentially stretch in one direction or on one part).The elastic matrix includes elastomer film or piece (for example, polyurethane Piece or thermoplastic elastomer (TPE) (TPE)), Woven fabric is (typically at least in part by elastomer filament, elastomer silk thread or elastomer Fiber weaving is formed), short fibre fabric (spun fabric) etc..In some embodiments, elastic matrix may include by elastic member Part (be usually silk thread, filament, fiber etc.) is woven, and with being disposed along outward flange and across the nothing extended laterally therebetween The fabric of flexible member, to provide expansion feature described above relative to power distributed architecture.That is, in some cases, Power distributed architecture can include the inelastic component for being woven in or being otherwise incorporated in fabric membrane or by such without bullet Property element is constituted.

Generally, power distributed architecture will include the single component of cut closure apparatus, such as including the outward flange with plate The spine of axially adjacent placement, and it is laterally positioned and from the spine towards the inward flange of plate extend it is multiple axially spaced Horizontal support piece.Such " pectination " structure will generally be formed by flexibility but nondistensible material, so as to element Can with the deformation of tissue flexing, but will not be stretched along its length together so that they can in a lateral direction with And provide dimensional stability along the outward flange of plate.The example of such material includes nylon, polypropylene, polyethylene and makrolon Or other thermoplastic polymers.It should be noted that power distributed architecture will not restriction plate inward flange axial tension, so as to outside In section's operative process desired expansivity and adaptability are provided to tissue.Such single power distributed architecture is attached It can be embedded in or be stacked in plate to the upper surface of plate, or alternatively.Generally, power distributed architecture will not be extended into or crossed The lower surface of plate so that it will not intervene plate to the adhesion of skin or its hetero-organization.

The assembly of substrate and power distributed architecture will be generally carried on removable backing, and the backing is using it Preceding covering and the adhesive surface of protection board.Can remove backing so as to by base portion be applied to surgical intervention position skin or its Hetero-organization.In addition, right panel and left plate generally will by removable auricle, axial bars band or other removable coverings or Structure keeps together, so as to which the inner surface of plate is maintained at into preset distance or spacing when plate is adhered to tissue.For example, can So that removable auricle is placed at each axial end of base portion, two substrates to be tightened together temporarily.Or, can So that removable band or adhesive tape are placed in the axial gap between left plate and right panel, to be adhered to tissue table in base portion Plate is held in place relative to each other during face.Such auricle or band generally would is that self-adhering type so that they can be tight Gu to plate, and and then in plate, correct placement is removed by simply shutting down after the tissue.Then it can remove and cover Cover material, auricle or band, so that plate is left in place but is not attached to before forming surgical incision therebetween.

First representative configuration of closing assembly or assembly includes right engagement member, left bonded block and multiple laterally branch Post, the multiple lateral struts keep the spaced preset distance of engagement member.Right engagement member is suitable to releasedly Its support member is engaged along the inward flange of right panel, and left engagement member is suitable to releasedly engage its branch along the inward flange of left plate Support member.In a specific embodiment, at least some support members in the support member of power distribution component, which will have, is located at its inner edge Chock (cleat) near edge, and engagement member will have the groove for receiving the chock.After surgical intervention completion, Then closing assembly can be placed on power distributed architecture, wherein the chock positioned at side is connect by an engagement member first Close, and relative engagement member is then pulled on the chock of opposite side.

Or, closing assembly or assembly can include multiple independent sway braces, and the tie-rod is attached at least one A little horizontal support pieces.Such sway brace is arranged to be fastened between horizontal support piece, is normally fixed to one On plate and it can be adjustably attached to another plate.For illustrative embodiments, can adjustably it be attached End can include ratch tensioning mechanism or similar structure, and the ratch tensioning mechanism or similar structure allow in right panel and a left side Between plate each sway brace is independently adjusted with different spacing.In this way it is possible to along right panel and the inward flange of left plate Differentially tensioning right panel and left plate, to control and optimize the power applied to the adjacent tissue edge being pulled together.

Optionally, closure apparatus of the invention may also include fastened layer, and the fastened layer is suitable in base portion and closing assembly On the otch that assembly has been fastened onto on patient skin and surgical procedures completed after be placed on the assembling On part.Fastened layer will generally have self-adhering type lower surface, and the self-adhering type lower surface can be placed on base portion and closing assembly Cleaned on assembly with helping to be fastened in place and holding.Fastened layer optionally has opening, to allow for observing Close to wound, delivering disinfectant etc..

In still another aspect of the invention, include providing otch as described above for forming the method for otch in the tissue Close apparatus.The right panel and left plate of the apparatus adhere to the skin of patient, wherein distance interval of the inward flange of plate to preselect Open, the distance is generally from 0.5mm to 15mm.Otch is formed on tissue or skin surface between the inward flange of plate (generally For straight line), and then separate incision tissue edge to carry out desired surgical procedures.The inward flange of plate can be with The movement and deformation of organization edge and stretch and comply with, and the outward flange of each plate and lateral extent dimensionally keep steady It is fixed.After operation technique is completed, closing assembly is fastened to power distributed architecture to retract the inward flange of plate together.Optionally Ground, closing assembly has organization edge than it just to form the size being more closely pulled together after otch (or adjustable Spacing between plates).So tissue is pulled together to cause edge to turn up and make tissue " corrugation ", scar shape can be so reduced Into.

There is provided cut closure apparatus in still another aspect of the invention.The cut closure apparatus may include left substrate and Right substrate, multiple closing assemblies for left substrate and right substrate laterally to be coupled, and correspondingly it is coupled to left substrate With multiple left axial supports of right substrate and right axial support.Each closing assembly include correspondingly coupled to left substrate and The left closing assembly end and right closing assembly end of right substrate.The multiple closing assembly can be horizontal across left plate and right panel Positioning, wherein (i) one or more described left axial supports are placed at least some axially adjacent left closing assembly ends Between, and (ii) one or more described right axial supports are placed at least some axially adjacent right closing assembly ends Between, to form snakelike arrangement.

In order to form snakelike arrangement, left axial support by every a pair of axially adjacent left closing assembly ends in left plate On be coupled, and/or right axial support by every a pair of axially adjacent right closing assembly ends on right panel It is coupled.The left plate and/or right panel can have one or more perforation, and one or more of perforation are arranged there between Between axially adjacent corresponding left/right closing assembly end without axial support.One or more of perforation can Including multiple such perforation：It contributes to the substrate in the axial tension of substrate to be separated into substrate section.

One or more of left substrate or right substrate can include multiple single substrate sections.At least two left closures Element end or at least two right closing assembly ends can be coupled to each substrate section.Left substrate can include multiple left substrates Section, and right substrate can include multiple right substrate sections.The left substrate section and the right substrate section can be in applications It is axially offset to one another when otch and surrounding tissue.The multiple closing assembly can by left substrate section and right substrate section that This transverse coupling gets up to form snakelike arrangement.

One or more of left substrate or right substrate can include tissue adhension lower surface, for adhering to adjacent to cutting The tissue of mouth.One or more of left substrate or right substrate can include lower adhesion layer and upper strata, and the lower adhesion layer includes The tissue adhension lower surface, and the upper strata includes upper surface.Upper strata can be harder than lower adhesion layer.Lower adhesion layer can have Have enough elasticity so that proper covering otch and during surrounding tissue due to being laterally adjacent to the tissue of the Tncision closing device The foaming moved and caused and adhesion loss minimize.The adhesion lower floor can include hydrophily adhesion material.It is described Hydrophily adhesion material may include the one or more in hydrocolloid, hydrogel, acrylate copolymer or PEG.It is described Upper strata can be included in rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE) (TPE), Woven fabric or short fibre fabric One or more.One in left closing assembly end, right closing assembly end, left axial support or right axial support Or multiple can be embedded in the upper surface of left substrate and right substrate or be laminated to the upper surface of left substrate and right substrate.

One or many in left closing assembly end, right closing assembly end, left axial support or right axial support It is individual to be formed by flexible not expandable material.

The multiple closing assembly, left axial support and right axial support can be hard enough, so that proper covering The movement of the tissue of the Tncision closing device is laterally adjacent to when otch and surrounding tissue does not make capped otch substantially With surrounding tissue expansion.Therefore, can be with the movement in the peripheral laterally adjacent the first tissue region of the Tncision closing device It is essentially converted to the identical in the minor microstructure region laterally adjacent and relative with the first tissue region with the periphery It is mobile.

One or more of the multiple closing assembly closing assembly can include tie-rod, and the tie-rod is coupled to securely Left closing assembly end or right closing assembly end, and it is adjustably attached to relative closing assembly end.It is described relative Closing assembly end can include ratch tensioning mechanism.

The multiple closing assembly can be arranged to the inward flange of left substrate and right substrate being pulled together, with compress by The otch that the cut closure apparatus is covered.

One or more of the multiple left axial support or the multiple right axial support can be C-shapeds.Institute Axial component and lateral part can each be included by stating C-shaped left and/or right axial support, and the axial component is used to limit phase Axially expanding for substrate is answered, and the lateral part is used for the lateral magnification for limiting corresponding substrate.

This aspect of the present invention may also provide the system for closing the otch in tissue.The system may include described Tncision closing device and flexible covers, the flexible covers are used to cover the Tncision closing device and capped otch And surrounding tissue.

Flexible covers can be configured to extend on the transverse edge and axial edge of left substrate and right substrate.It is described to cover Cover material can have one or more perforation, to allow the covering in response to cutting for being covered by the Tncision closing device Mouthful and surrounding tissue axial tension and axial tension at least in part.One or more of perforation can be along covering Central axis is disposed.Covering can include one or more strenthening members, and one or more of strenthening members are coupled to institute State at least a portion of the adhesion layer of covering.Strenthening member can include rubber, latex, urethane, polyurethane, silicone, thermoplastic One or more in property elastomer (TPE), Woven fabric or short fibre fabric.Covering can include hydrophily adhesion layer, should Hydrophily adhesion layer can include the one or more in hydrocolloid, hydrogel, acrylate copolymer or PEG.

There is provided a kind of cut closure apparatus in still another aspect of the invention.The cut closure apparatus includes flexible adhesive Bottom, intermediate layer and top layer.The flexible adhesive bottom can have the first elasticity.The intermediate layer can be coupled to and cover described At least a portion of flexible adhesive layer, and with the second elasticity for being less than the described first elasticity.The top layer can be coupled to simultaneously At least a portion in the intermediate layer is covered, and with the 3rd elasticity for being less than the described second elasticity.The flexible adhesive bottom Tension gradient between layer and the top layer can provide enough rigidity for the cut closure apparatus, so that proper covering is cut Mouthful and the movement of the tissue that is laterally adjacent to the apparatus during surrounding tissue do not make capped otch and surrounding tissue substantially Expansion.

The tension gradient can provide enough elasticity for cut closure apparatus, so that proper covering otch and surrounding group The foaming caused when knitting due to the movement of the tissue adjacent to the apparatus and adhesion loss are minimized.

Cut closure apparatus can be in response to the otch covered by the cut closure apparatus and the axial direction of surrounding tissue Stretching and be flexible in the axial direction.Movement with the peripheral adjacent the first tissue region of flexible adhesive bottom can be substantially It is converted into the identical in the minor microstructure region peripheral adjacent and relative with the first tissue region with flexible adhesive bottom It is mobile.

Flexible adhesive bottom can include hydrophily adhesion material.The hydrophily adhesion material can include hydrocolloid, One or more in hydrogel, acrylate copolymer or PEG.

The upper strata can include rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE) (TPE), Woven fabric Or the one or more in short fibre fabric.

Flexible adhesive bottom can include the first adhesion sublayer and the second adhesion sublayer.Intermediate layer can include being coupled to institute State the first upper strata and the second upper strata coupled to second adhesion sublayer of the first adhesion sublayer.Top layer can include multiple axles The arrangement of multiple horizontal closing assemblies to supporting construction and coupled to the axial support structure, for described first to be adhered to Bottom and first upper strata are fastened to second adhesion sublayer and second upper strata.The multiple axial support structure and The multiple closing assembly can be with coupled to each other to form serpentine pattern, for allowing the lower adhesion layer or the intermediate layer One or more of in response to the otch and the axial tension of surrounding tissue that are covered by the Tncision closing device and in institute State and stretched at least in part on the axial direction of closing device.The multiple axial support structure and the multiple horizontal closed group Part can form scalariform pattern with coupled to each other.One in the multiple axial support structure or the multiple horizontal closing assembly It is individual or multiple can be formed by flexible not expandable material.The multiple horizontal closing assembly can be arranged at flexible adhesive bottom After the tissue for the opposite sides that layer adheres to otch, by first adhesion sublayer or the second adhesion sublayer and described first The inward flange on one or more of upper strata or the second upper strata is pulled together.One or more of described horizontal closing assembly can So that including left-end point, right end and tie-rod, the tie-rod coupled to the left-end point or right end and can adjust securely Ground is attached to relative end.One or more of the multiple axial support structure or the multiple horizontal closing assembly can To be embedded in first upper strata and the second upper strata or be laminated to first upper strata and the second upper strata.

This aspect of the present invention may also provide the system for closing the otch in tissue.The system includes described cut Mouthful closure apparatus and flexible covers, the flexible covers be used to covering the cut closure apparatus and capped otch and Surrounding tissue.

Flexible covers can be configured to extend on the transverse edge and axial edge of the flexible adhesive bottom.It is described Covering can have one or more perforation, to allow the covering in response to being covered by the cut closure apparatus Otch and the axial tension of surrounding tissue and at least in part on the axial direction of the covering stretch.It is one or many Individual perforation can be disposed along the central axis of covering.Covering can include one or more strenthening members, one Or multiple strenthening members are coupled at least a portion of the adhesion layer of the covering.The strenthening member can comprising rubber, One or more in latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE) (TPE), Woven fabric or short fibre fabric.Covering Thing can include hydrophily adhesion layer.The hydrophily adhesion layer can include hydrocolloid, hydrogel, acrylate copolymer or poly- One or more in (ethylene glycol).

There is provided a kind of cut closure apparatus in still another aspect of the invention.The cut closure apparatus may include there is the One elasticity lower part, with less than described first elasticity second elasticity upper part, and the lower part with it is described on Tension gradient between part.The tension gradient can provide enough rigidity for the cut closure apparatus, so that proper The movement of covering otch and the tissue for being laterally adjacent to the apparatus during surrounding tissue does not make capped otch and week substantially Enclose tissue bulking.The tension gradient can provide enough elasticity for the cut closure apparatus, so that proper covering otch The foaming caused during with surrounding tissue due to the movement for the tissue for being laterally adjacent to the apparatus and adhesion loss are minimized.

There is provided a kind of cut closure apparatus in still another aspect of the invention.The cut closure apparatus may include comprising a left side The base portion of plate and right panel, left power distributed architecture and right power distributed architecture, and multiple closing assemblies.Each plate can have tissue Adhere to lower surface, upper surface, the first transverse edge, the second transverse edge.The left power distributed architecture and right power distributed architecture can To be correspondingly coupled to the left plate and right panel.Each power distributed architecture may be adapted to allow the plate horizontal along described first One of edge or the second transverse edge are axially expanded, and suitable for limitation across the lateral magnification of the plate and along relative Transverse edge is axially expanded.The multiple closing assembly can be fastened to the left plate and right panel, to be adhered in the plate The plate is pulled together after tissue and the otch formed therebetween.

First transverse edge of each plate can include the inward flange of each plate.The inward flange of each plate can be towards that This.

Second transverse edge of each plate can include the outward flange of each plate.The outward flange of each plate can dorsad that This.

One or more of left plate and right panel of base portion can include elastic matrix.The elastic matrix can include bullet Property body film, Woven fabric or short fibre fabric.The elastic matrix can include it is woven by flexible member, and with along institute State the first transverse edge or the second transverse edge and across the fabric of the inelastic component extended laterally therebetween.

Each power distributed architecture can include the spine for first transverse edge placement for being located axially adjacent to the plate, with And multiple axially-spaced horizontal branch that are laterally positioned and extending from the spine towards first transverse edge of the plate Support member.The spine and horizontal support piece can be formed by flexible not expandable material.The power distributed architecture can be embedded in often In the upper surface of individual plate or it is laminated to the upper surface of each plate.

Closing assembly can include right engagement member, left engagement member and multiple lateral struts, the multiple laterally branch Post keeps the spaced preset distance of engagement member.The right engagement member may be adapted to be releasably engaged right panel Support member, and the left engagement member may be adapted to the support member for being releasably engaged left plate.In the support member at least Some support members can have the chock close to one or more of first transverse edge or the second transverse edge, and The engagement member can have the groove for receiving the chock.The lateral struts can be adjustably coupled to the engagement structure At least one in part, to allow the regulation of the preset distance.The closing assembly can include multiple independent transverse ties Bar, the multiple independent sway brace is attached at least some horizontal support pieces in the horizontal support piece.The transverse direction Tie-rod can be arranged to be fastened between horizontal support piece.The independent sway brace, which can each have, is fixed to plate One end, and it is adjustably attached to the second end of another plate.The second end can include ratch tensioning mechanism.

The cut closure apparatus can also include fastened layer, and the fastened layer is suitable in the base portion and the closing assembly Assembly be anchored on the otch on patient skin after, be placed on the assembly.The fastened layer can have There is self-adhering type inner surface.

Brief description of the drawings

Fig. 1 is the exploded view of the cut closure apparatus built according to the principle of the invention.

Fig. 2 is the top view as the base portion of a part for cut closure apparatus and the assembly of power distributed architecture.

Fig. 3 is the profile along Fig. 2 line 3-3 interceptions.

Fig. 4-Fig. 7 illustrates using the cut closure apparatus of the present invention to form and close the otch in patient skin.

Fig. 8 illustrates the constructive alternative of the closing assembly of the closure apparatus of the present invention.

Fig. 9 is the exploded view of the further embodiment of the cut closure apparatus built according to the principle of the invention.

Figure 10 is the base portion of Fig. 9 system and the amplification isometric view of power distributed architecture.

Figure 11 A and Figure 11 B illustrate the alternative sway brace construction that can be used in Fig. 1 or Fig. 9 apparatus.

Figure 12 illustrates the sacrifice covering being positioned on cut closure apparatus in accordance with the principles of the present invention.

Figure 13 A to Figure 13 E illustrate shown in Figure 12 sacrifice covering with according to the present invention surgical incision drop cloth Operating principle and execution method when being used together.

Figure 14 A1- Figure 14 A3 are the perspectives of the further embodiment of the cut closure apparatus built according to the principle of the invention Figure.

Figure 14 B are according to the similar to Figure 14 A- Figure 14 A3 cut closure apparatus of the present invention and are positioned over subject's knee On cut closure apparatus top view.

Figure 15 A show cutting according to the principle of the invention, with the pulley system to two adjacent substrates of transverse coupling The schematic diagram of mouth closure apparatus.

Figure 15 B show the profile of Figure 15 A cut closure apparatus.

Figure 15 C show the cut closure apparatus according to the present invention, Figure 15 A being positioned on model knee.

Figure 15 D show the schematic diagram of the cut closure apparatus similar to Figure 15 A cut closure apparatus.

Figure 15 E and Figure 15 F respectively illustrate for Figure 15 A and Figure 15 D cut closure apparatus be used together it is various Sway brace assembly structure.

Figure 16 A- Figure 16 D show various retaining mechanisms in accordance with the principles of the present invention.

Figure 17 shows the linkwork according to the principle of the invention, for cut closure apparatus.

Figure 18 is similar according to the principle of the invention, to Figure 14 A cut closure apparatus and is positioned on subject's knee The top view of cut closure apparatus.

Figure 19 is shown includes the cut closure apparatus of single substrate section pair according to the present invention's.

Figure 20 A show the cut closure apparatus similar according to the principle of the invention, to Fig. 9 and Figure 10 cut closure apparatus Perspective view.

Figure 20 B show the zoomed-in view of the sway brace assembly of Figure 20 A cut closure apparatus.

Figure 21 shows the exploded view of a part for Figure 21 cut closure apparatus.

Figure 22 A show the perspective of covering in accordance with the principles of the present invention, for cut closure apparatus disclosed herein Figure.

Figure 22 B show the exploded view of Figure 22 A covering.

Figure 23 A show cutting in accordance with the principles of the present invention including Figure 21 cut closure apparatus and Figure 22 A covering The exploded view of mouth closure apparatus assembly.

Figure 23 B show the perspective view of Figure 23 A adhered on patient skin cut closure apparatus assembly.

Figure 23 C show the top view of the elastomer back-up coat of Figure 22 A covering.

Figure 24 A show Figure 23 A that are in accordance with the principles of the present invention, adhering on patient skin cut closure apparatus assembling The perspective view of part.

Figure 24 B show cuing open for Figure 23 A that are in accordance with the principles of the present invention, adhering on patient skin cut closure apparatus Face schematic diagram.

Figure 25 A- Figure 25 C illustrate in accordance with the principles of the present invention, the application drawing 23A on patient skin cut closure apparatus The method of assembly.

Figure 26 A- Figure 26 E illustrate it is in accordance with the principles of the present invention, for wound dressing and the covering of cut closure apparatus Embodiment.

Figure 27 A- Figure 27 E illustrate the wound closure of pharmaceutical preparation in accordance with the principles of the present invention, with merging thereon The embodiment of apparatus.

Figure 28 A- Figure 28 E illustrate the wound closure of pharmaceutical preparation in accordance with the principles of the present invention, with merging thereon The embodiment of device coverings.

Figure 29 is illustrated according to the principle of the invention, another sacrifice covering being positioned on cut closure apparatus.

Embodiment

The apparatus and method of the present invention will be used in be made during outer section's operation technique to patient skin or its hetero-organization Surgical incision formation and closing course in.As described below, the direction of otch will be limited " axial direction " used herein " transverse direction " direction.Most of otch will be made along substantially straight line, and the line will limit axial direction.Horizontal direction Will be generally but not certain perpendicular or normal to axial direction substantially across axial direction.Most of otch will be substantially Straight line, but in some cases otch be probably bending or with other geometries.Term " axial direction " then will Suitable for the direction for the otch for being in any specific location, so as to produce also transformable horizontal direction.

With reference to Fig. 1-Fig. 3, cut closure apparatus 10 includes base portion assembly 12, and the base portion assembly 12 includes the He of right panel 14 Left plate 16.Right power distributed architecture 18 is fastened to right panel 14, tight typically by the upper surface that power distributed architecture is laminated to plate Gu；And left power distributed architecture 20 is similarly attached to the upper surface of left plate 16.Cut closure apparatus also includes closing assembly 22, The closing assembly 22 can be removably attachable to right power distributed architecture 18 and left power distribution knot as described in more detail below Structure 20 is so as to close incisions, and the apparatus also includes optional fastened layer 24, the fastened layer 24 can combination base portion Assembly 12 and closing assembly 22 have been secured to patient and have been pulled together the plate by using closing assembly and make It is placed on after cut closure on the base portion assembly 12 of combination and closing assembly 22.

Closing assembly 22 is intended to and suitable for power distributed architecture 18 and power distributed architecture 22 are pulled inwardly toward each other, to close Close the surgical incision formed therebetween.In the embodiment shown, in the ridge by power distributed architecture 18 and power distributed architecture 20 Multiple chocks 26 are formed on the horizontal support piece 36 that portion 37 is axially retained.Chock 26 is accepted in groove 38, the groove 38 along The inward flange of the relative engagement member 40 of closing assembly 22 is formed.The relative engagement member 40 is kept by lateral struts 42 Together, to make engagement member keep fixed, spaced distance, (in other embodiments, spacing distance can To be adjustable).Groove 38 can be preferably formed in flexible ear laminated structure 44, and this allows on corresponding chock upwards The groove is pulled, so as to which closing assembly 22 is anchored on power distributed architecture 18 and power distributed architecture 20.

The lower surface 32 of each plate 18 and 20 generally will be covered with pressure-responsive adhesive, wherein described adhesive most Matcoveredn 48 is just covered, the protective layer 48 can be peeled off just before the use.It is furthermore possible to also provide be pulled away from auricle 50 or other Similar structure, so as to after the removed layer 48 and before plate to be adhered to patient skin or other tissue surfaces Distance keeps together right panel 14 and left plate 16 at a predetermined interval.Importantly, as far as possible with original object spacing closely Keep the distance between inward flange 28 of each plate 14 and 16 so that organization edge will be smart when being closed by closing assembly 22 Really gather together, generally slightly turn up.

With reference to Fig. 4 to Fig. 7, it will description it is in accordance with the principles of the present invention, for forming otch and in subsequent close incisions Scheme.First, as shown in Figure 4, right panel 14 and left plate 16 are placed on the patient skin marked by reference letter S.Pass through Protective layer 18 is pulled away from first and plate is placed into tissue and plate 14 and plate 16 is applied, and auricle 50 can be removed after this, from And leave the kerf path 52 being defined between inward flange 28.It is fixed pre- to provide that the spacing of inward flange 28 will be selected Set a distance d₁。

Right panel 14 and left plate 16 in place after, as shown in Figure 5, scalpel or other electrosurgical cutting devices can be used Otch I is formed in the spaces of CD between the plates.

After otch I is made, as shown in Figure 6, surgical procedures can be carried out by beating scalloping inward flange, This transfers to deform right panel 14 and the inward flange of left plate 16 28.Because the most inside end of support member 36 is not connected, therefore it Can be freely separating and allow right panel 14 and the expansion of the elastic matrix of left plate 16, be clearly shown in such as Fig. 6.However, plate The dimensional stability of remainder will be kept by horizontal support piece 36 and axial ridges 37, the horizontal support piece 36 and axle It will not extended to spine 37 under the influence of stretching open the power that otch is applied.

As shown in Figure 7, after surgical procedures completion, closing assembly 22 will be fastened onto power distributed architecture 18 On power distributed architecture 20.Specifically, the groove 38 in ear laminated structure 44 is engaged on relative chock 26, so as to by plate Opposite edges and tissue cut be pulled together.By being appropriately spaced the depth of the groove 38, closed group can be adjusted Part 22, so as to by plate 14 and plate 16 with preselected distance d₂Gather together.Generally, apart from d₂Initial gap d will be less than₁, so as to The inward flange of tissue is gathered together to cause organization edge somewhat to be turned up (corrugation upwards) along otch, can so improved Healing and reduction cicatrization.

Optionally, as shown in Figure 8, closing assembly 22' can include engagement member 40', wherein passing through adjustable buckle Hook or other mechanisms 54 link an each lateral struts 42' end, so as to adjust the interior of relative engagement member 40' The distance between edge, with increase or reduce therebetween apart from d₂。

The alternate embodiment 100 of the cut closure apparatus of the present invention is illustrated in figure 9 and in figure 10.Apparatus 100 includes Base portion assembly 102, the base portion assembly 102 has right panel 104 and left plate 106.As being best shown in Figure 10, positioning or right Floating screed band 108 is provided for tightening together the inward flange of each plate, and the positioning or aligned stripes 108 include end Auricle 109, the end auricle 109 allows user after plate 104 and plate 106 are in place on tissue surface from institute State plate and pull out the band.

Cut closure apparatus 100 also includes backing 110, and the backing 110 has the end that can partly turn back, will be following Adhesion backing on the plate, and allow the end of base portion assembly 102 adhering to tissue, while making base portion group The remainder of piece installing is still covered by the backing.Offer includes the fastened layer 112 of reinforcing frame 113, in base portion group Piece installing 102 is placed on right panel 104 and left plate 106 after being closed on otch, and this is generally related to prior embodiments Ground is described.Generally, it will provide and keep pallet 114, for aseptically the component of apparatus to keep together, wherein holding in the palm Disk 114 will be covered by conventional medical package covering.

As shown in figs. 9 and 10, right power distributed architecture is correspondingly provided on the upper surface of right panel 104 and left plate 106 116 and left power distributed architecture 118.Right power distributed architecture 116 includes right axial ridges 120 and multiple horizontal support pieces 122.It is logical Often, right axial ridges 120 include snakelike or serrated member, and the snakelike or serrated member is embedded in or be laminated to base portion band 121.Snakelike axial ridges 120 will generally be formed by flexible elastoplast (being usually duroplasts), and base portion band 121 Polyurethane or similar plastic layer will be included.The lower surface of layer of polyurethane will be covered with hydrocolloid layer, for tissue adhension. The structure of left power distributed architecture 118 would is that identical, including left axial ridges 124, left horizontal support piece 126 and left base portion bar Band 127.

As shown in Figure 9, cut closure apparatus 100 will include close mechanism, and the close mechanism includes multiple transverse ties Bar assembly 128.Best seen from each sway brace assembly 128 will include bar and ratch mechanism in such as Figure 10 (ratchet mechanism) 132, the bar is anchored on an end of left horizontal support piece 126, and the ratch mechanism 132 are fastened to right horizontal support piece 122.Each bar 130 will be generally aligned with the axis of the part of left plate 106 so that right panel 104 Gap 129 between left plate 106 will keep unlimited, so as to make otch therebetween.After otch is made, it will Each bar 130 is moved to the ratch 132 associated on right panel 104.A series of ratch rings on each bar will be pulled in association In ratch mechanism 132, and the bar is then laterally pulled, until being applied with expectation along the point of base portion assembly 102 Closure tension force.It is particularly advantageous in that, can individually adjusts each sway brace assembly 128, so as to along is closed There is provided inter-organization desired closure tension force for the length of the otch of conjunction.Once provide desired close along whole otch Close tension force, you can fastened layer 112 is placed on base portion assembly 102, the apparatus and tissue are kept in place.

With reference to Figure 11 A and Figure 11 B, the alternative design of the sway brace assembly 140 of the present invention is shown in figure.These are horizontal It can be used together to tie-rod assembly 140 with any one in previously described cut closure apparatus 10 or 100.Each transverse tie Bar assembly 140 includes right power distributed architecture 142 and left power distributed architecture 144.Right power distributed architecture includes right spine 146 and many Individual horizontal support piece 148.Though it is shown that three horizontal support pieces, it is to be understood that, 4,5,6 or more can also be included Multiple horizontal support pieces.Left spine 150 and multiple left horizontal support pieces 152 is similarly included in left power distributed architecture 144.In order to carry For closure, right power distributed architecture 142 includes the bar 154 extended from center horizontal support piece 148.Generally, bar 154 by actively or by Dynamic connecting piece 158 is linked to the support member.Draw ring 156 is provided in the free terminal of bar 154, and along the stage casing of bar 154 Part provides multiple ratchets 162.

Left power distributed architecture 144 includes ratch mechanism 160, and the ratch mechanism 160 is suitable to the bar for receiving right power distributed architecture Tooth 162 on 154.By this way, bar 154 can be made to fall into soldered tooth 162 in ratch 160, so as to allow to promote institute forward Bar is stated, so as to which right power distributed architecture 142 and left power distributed architecture 144 are pulled together, to apply tension force to right panel and left plate.

As shown in Figure 12, another aspect of the present invention is shown in figure.Schematically illustrate cut closure apparatus 100, wherein illustrate only right panel 104 and left plate 106 and right power distributed architecture 116 and left power distributed architecture 118.Remaining is Component of uniting is not shown for the ease of diagram.

Right panel 104 is covered by right sacrifice covering (sacrificial cover) 170, and left plate 106 is sacrificed by left Covering 172 is covered.Right panel 104 and left plate 106 can be right wherein to sacrifice covering 170 and left sacrifice with limited area 175 Covering 172 separates right panel 104 and left plate 106.Covering 170 and 172 is each removably along the substrate of association Each edge fastening so that covering is in normal process of the cut closure apparatus 100 on the tissue surface to be cut and puts Kept during putting in situ.Use and the purposes that these sacrifice covering 170 and 172 are described with reference to Figure 13 A and Figure 13 E.

Figure 13 A illustrate right panel 104 in place on tissue surface T before otch is made and left plate 106.Right panel 104 Covered by right sacrifice covering 170, and left plate 106 is covered by left sacrifice covering 172.Such as it is common in many surgery hands In art like that, adhesion surgical incision drop cloth 180 is placed on tissue surface T.Any conventional drop cloth can be used, such as can be from bright The Ioban that Ni Su Dazhou City St.Paul 3M is bought^TMAntimicrobial otch drop cloth.

After otch drop cloth 180 is in place on cut closure apparatus, it is desired for carrying out to make surgical incision I Surgical intervention.As seen in FIG., otch correspondingly can be cut out right panel 104 and left plate 106 through surgical drape 180 I.After surgical procedures are completed, it will remove surgical drape 180 from tissue surface T.Because surgical drape has lower glue Subordinate list face, therefore before making the present invention, the removal of drop cloth may make any of right panel 104 and left plate 106 or all both move Position.However, the presence of sacrifice layer 170 and sacrifice layer 172 prevents such displacement.The removal of surgical drape 180 will be removed Sacrifice layer 170 and sacrifice layer 172, but because each layer in these layers is arranged to break with relatively low separating force From, therefore the removal of sacrifice layer will not result in following plate 104 or plate 106 is shifted.Therefore, plate 104 and plate 106 will be as Stayed put shown in Figure 13 D, and as shown in Figure 13 E, power distributed architecture 116 and power can be used as previously described Distributed architecture 118 is by plate closing together so as to close incisions.

With reference to Figure 29, right sacrifice blanket layer 170 and left sacrifice blanket layer 172 can each free urethane film (for example, 0.001 " is thick) it is built-up.The middle part of urethane piece can be adhered the top to right panel 104 and left plate 106, and by power distributed architecture 116th, power distributed architecture 118 and any band 130 and lock 132 are assembled on urethane piece.Then urethane piece can be wound Around power distributed architecture 116, power distributed architecture 118 (and band 130 can curve inwardly as shown in Figure 29 so that They are comprised on plate 106), and the free terminal of urethane piece is stacked on one another along its length.It therefore, it can twine urethane piece It is wound on power distributed architecture 116, power distributed architecture 118 and closure member 130, on closure member 132, it is outer to protect them from Section's drop cloth 180 influences.Urethane piece preferably include multiple perforation, it is the multiple perforation along its length placement, and with it is every Individual plate 104, the inward flange 104e of plate 106 and outward flange 106e alignments.The perforation can allow removing surgical drape (example Such as, surgical drape 180 as described herein) when, tear urethane piece with surgical drape 180 in a controlled manner.Perforation preferably by 3mm otch and 1mm tie-rods is built-up, but can also change definite size to control desired tear edge.Perforation can be along Single ordinate or multiple lines and formed.Multiple longitudinal perforation lines can allow reliable separation, regardless of whether surgical drape with it is sacrificial Change in domestic animal layer 170, the adhesion of sacrifice layer 172.Can will perforate be made for easily close to plate 104,106 edge it Place unclamps, and to help the possibility for improving the separation at plate 104, edge 104e, 106e of plate 106, and makes what is left Unnecessary urethane minimize.In order to help sacrifice layer 170, sacrifice layer 172 to lift, auricle 170t, auricle 172t can be glued It is attached to comprising sacrifice layer 170, each end of the urethane bag of sacrifice layer 172.Auricle 170t, auricle 172t can be adhered to preferably To the inside of the upper surface of urethane bag.Auricle 170t, auricle 172t can be shaped to prevent urethane to the adhesion of its own or To any adhesion from each plate 104, the adhesive of the ends exposed of plate 106.Each plate 104, the perforation of the end of plate 106 Pre- fracture can help to auricle 170t, auricle 172t and initially lift and initiation of the user to tear.

With reference to Figure 14 A1- Figure 14 A3, the further embodiment of cut closure apparatus is shown in figure.Base portion assembly 1400a (Figure 14 A1), base portion assembly 1400b (Figure 14 A2) and base portion assembly 1400c (Figure 14 A3) can each include right base Plate 1402 and left substrate 1404.Right substrate 1402 may include upper strata 1406 and lower floor 1408.Similarly, left substrate 1404 may include Upper strata 1410 and lower floor 1412.Upper strata 1406,1410 generally would is that flexibility, but hard enough, to securely close tissue And minimize the upset to otch and surrounding tissue.Upper strata 1406,1410 may include plastic layer, and the plastic layer is by rubber, breast Glue, polyurethane, silicone, thermoplastic elastomer (TPE), Woven fabric, short fibre fabric or similar material are made.Adhesion sublayer 1408, 1412 generally would is that flexibility, and more flexible than upper strata 1406,1410, to follow any of following skin and tissue It is mobile, so as to keep adhering to, foaming is minimized and in addition reduce stimulation.Adhesion sublayer 1408,1412 may include parent Aqueous adhesion material, hydrocolloid, hydrogel, acrylate copolymer, PEG etc..

Right substrate 1402 and left substrate 1404 may include to promote and limit base portion assembly 1400 axially and transversely The structure of stretching.These structures can also be evenly distributed the closing force put on otch, and can be assembled along base portion Part 1400a, base portion assembly 1400b and base portion assembly 1400c axial length are placed on them.Right substrate 1402 can Including one or more right power distributed architectures or axial support 1414.Each right axial support 1414 may include axial branch Support part is divided to or spine 1414a and two cross-brace part 1414b, the cross-brace part 1414b are coupled to spine 1414a axial end.Spine 1414a and described two cross-brace part 1414b form C-shaped together, and the C-shaped is in some realities Applying can axially open in mode to a certain degree, to promote right substrate 1402 laterally adjacent at two of adjacent supporting piece 1414 Cross-brace part 1414b between axial tension, while being limited in two cross-brace parts of single support member 1414 Axial tension between 1414b.In many embodiments, C-shaped axial support 1414 only has and is enough to allow vertical deflection Flexibility, but be hard to minimize axial tension and cross directional stretch.As shown in Figure 14 A1, right axial support 1414 can be inward-facing.As shown in Figure 14 A2 and Figure 14 A3, right axial support 1414 can be faced out, and this can To help the otch I being distributed to any mechanical load for tissue closure between right substrate 1402 and left substrate 1404.Class As, left substrate 1404 may include one or more left power distributed architectures or axial support 1416.Each left axial support 1416 may include axial support portion or spine 1416a and two cross-brace part 1416b, the cross-brace part 1416b is coupled to spine 1416a axial end.Spine 1416a and described two cross-brace part 1416b form C together Shape, the C-shaped can be opened axially to a certain degree, to promote left substrate 1402 in adjacent supporting piece in some embodiments Axial tension between 1416 two laterally adjacent cross-brace part 1416b, while being limited in single support member 1416 Two cross-brace part 1416b between axial tension.In many embodiments, C-shaped axial support 1416 only has Have and be enough the flexibility for allowing vertical deflection, but be hard to minimize axial tension and cross directional stretch.Such as Figure 14 A1 Shown in, left axial support 1416 can be inward-facing.As shown in Figure 14 A2 and Figure 14 A3, left axial support 1416 It can face out, this can help any mechanical load for tissue closure being distributed to right substrate 1402 and left substrate Otch I between 1404.

As shown in Figure 14 A3, substrate in batch piece installing 1400c may also include skirt section 1424 and skirt section 1426.Skirt section 1424, 1426 can be similar to thin base portion assembly covering described below.For example, each skirt section 1424,1426 may include 0.001 English Very little thick urethane film, the urethane film is coupled to the acryloid cement of 0.002 inch.Adhesive can put on skirt section 1424th, 1426 whole lower surface, or can be applied only to skirt section 1424,1426 beyond substrate 1402 or substrate 1404 Region.In substrate in batch piece installing 1400c building process, skirt section 1424,1426 can correspondingly directly apply to whole adhesions On layer 1408,1412 or one part.Correspondingly it can come alternately or additionally in film upper strata using skirt section 1424,1426 1406、1410.Cable release as described herein can be further provided for rule the adhesion lower surface in skirt section 1424,1426. Skirt section 1424,1426 can each extend over beyond substrate 1402,1404 external boundary reach such as 8mm or 1 to 20mm in the range of, but The not transverse area between substrate 1402,1404, to improve the ability for being visualized and/or being cleaned to cutting part. Therefore, skirt section 1424,1426 can help to provide additional adhesion support to the adhesion layer 1408,1412 of substrate 1402,1404 And/or creep reduces, without being directed at and placing single covering or covering piece in substrate in batch piece installing 1400.In manufacture Afterwards, skirt section 1424,1426 is generally accurately aligned with relative to substrate 1402,1404.Still it can use described herein Single covering or covering piece prevent the play of cutting part and substrate in batch piece installing 1400c component.Due to skirt section 1424th, 1426 extended laterally respectively on substrate 1402,1404, therefore such single covering or covering piece can With accurate placement that need not be relative to substrate in batch piece installing 1400c, and with other coverings as described herein or covering piece Compared to can be with narrower.

One or more perforation 1418 can be provided between the axially adjacent right axial support 1414 of right panel 1402, To promote the axially and/or laterally stretching of right panel 1402.Perforation 1418 can be through upper strata 1406 and lower floor 1408 with to following Tissue ventilation is provided, or can be only present on upper strata 1406.Similarly, can be on an axially adjacent left side for left plate 1404 One or more perforation 1420 are provided between axial support 1416, to promote the axially and/or laterally stretching of substrate 1402.Wear Hole 1420 can run through upper strata 1410 and lower floor 1412 to provide ventilation to following tissue, or can be only present in upper strata On 1410.As shown in Figure 14 A1, can only have single perforation 1418 or 1420 between axial support 1414 or 1418. As shown in Figure 14 A2 and 14A3, there can be the multiple perforation 1418 for lining up x wire between axial support 1414 or 1418 Or 1420.Perforation 1418,1420 can also reduce because skin is radially outward stretched (such as, in joint motions or swollen from otch I Swollen period) caused by stress.

For example, can be along the right line 1424 and left line 1426 shown in Figure 14 B on right axial support 1414 and/or a left side Multiple perforation 1418,1420 are provided between the axial end of axial support 1416.Can be on each line segment 1424 or 1426 Multiple axially aligned perforation are provided, so that at least the upper strata 1410 of substrate 1402,1404 and lower floor 1412 can be entered with following article The description of one step is broken into single section respectively when by axial tension like that.In some cases, wearing in device 1400 Period, perforation 1418,1420 can allow the layer 1406 and 1408 of right panel 1402 and the layer 1410 and 1412 of left plate 1404 to exist Fully separate and separate at perforation line, this shows in Figure 14 A2 and Figure 14 A3.Completely separable and separation ability is further Allow as needed and axial tension skin, wherein by axial support 1414 and 1416 discussed below and closing assembly 1422 connection (and limitation) elongation allowing.As described herein, can be in substrate 1402,1404 after otch I closures Upper application flexibility, compliance covering.The covering can be further used for providing (and limitation) base structure 1400b axle To mobile and transverse shifting.Alternatively or in combination, can be between power distributed architecture or axial support 1414,1416 laterally One or more of right substrate 1402 or left substrate 1404 are cut and separate, to promote right substrate 1402 and/or left substrate 1404 axially and/or laterally stretching.

In order to by right substrate 1402 together with the left transverse coupling of substrate 1404 and optionally in order to by right substrate 1402 Tensed against each other with left substrate 1404, base portion assembly 1400 may also include multiple horizontal closing assemblies or tie-rod assembly 1422.Horizontal closing assembly or tie-rod assembly 1422 may include the tooth with sway brace assembly described above 128 and 140 The similar ratch mechanism of linkage.Sway brace assembly 1422 can be by laterally adjacent right axial support 1414 and left axle It is coupled to support member 1416, is typically axially end coupling.As shown in Figure 14 A1- Figure 14 A3, right axle is to branch The corresponding placement of support member 1414 and left axial support 1416 on right panel 1402 and left plate 1404 can be staggeredly or axially Skew, and right axial support 1414 and left axial support 1416 can be C-shaped configurations, and the C-shaped configuration has each other Laterally face and be aligned lateral end portions 1414b, 1416b of (and being connected with each other by sway brace assembly 1422). For example, the remote end lateral part 1414b of the first right axial support 1414 can be with the first left axial support 1416 nearly end End lateral part 1416b is laterally aligned to, and the remote end lateral part 1416b of the first left axial support 1416 can be with second right side The proximal end lateral part 1414b of axial support 1414 is laterally aligned to, and so on.Therefore, sway brace assembly 1422 and right axial support 1414 and left axial support 1416 can be joined to one another, to form continuous transverse tie The line of bar assembly 1422 and right axial support 1414 and left axial support 1416, and the line can have snakelike cloth Put, the snakelike arrangement (that is, passes through right base as shown in Figure 14 A1- Figure 14 A3 laterally across right substrate 1402 and left substrate 1404 The distance between plate 1402 and left substrate 1404).Sway brace assembly 1422 and right axial support 1414 and left axle to The snakelike arrangement of support member 1416 can be realized following one or more：The closing force that base portion assembly 1400 is provided is uniform It is distributed on otch；The axial elasticity of (and limitation) base portion assembly 1400 is provided；And be base portion assembly 1400a, 1400b Hardness or rigidity are provided with fully close incisions with 1400c and allow it to be healed (i.e., with the upset and expansion that minimize There is provided lateral stability and axial stability).In many embodiments, horizontal support piece 1414,1416 is hard so that The region stretching of substrate 1402,1404 not covered with horizontal support piece 1414,1416.Due to these uncovered regions from Right substrate 1402 is offset from one another to left substrate 1404, thus tie-rod assembly 1422 can with otch I by axial tension from Its anchor point is axially pivoting.Tie-rod assembly 1422 it is such it is axially pivoting can be by right substrate 1402 and left substrate 1404 more Closely gather together, to keep otch I closure.

Sway brace assembly 1422 and the material of right axial support 1414 and left axial support 1416 can examples Such as include flexible elastoplast, usually duroplasts, such as nylon, polypropylene, polyethylene, makrolon or other thermoplasticity Polymer.Generally, sway brace assembly 1422 and right axial support 1414 and left axial support 1416 can include bullet Property be less than the material of right substrate 1402 and left substrate 1404.Therefore, it is many other with cut closure apparatus disclosed herein Base portion assembly is the same, and bigger rigidity can be provided towards base portion assembly 1400a, 1400b and 1400c top (and more Small elasticity).That is, there may be elasticity between base portion assembly 1400a, 1400b and 1400c top and bottom Gradient.Base portion assembly 1400a, 1400b and 1400c top can be hard enough or firm so that cut closure apparatus exists Prevent from being laterally adjacent to the movement of the tissue of the apparatus during applied to otch and surrounding tissue, do not make so as to substantially capped Otch and surrounding tissue expansion.That is, at least a portion of the cut closure apparatus of application is (for example, under harder layer Part) movement be overall, and do not upset following otch.Also, base portion assembly 1400a, 1400b and 1400c Bottom can be flexible enough, to cause the foaming caused by adjacent to the movement of the tissue for the cut closure apparatus applied Minimized with adhesion loss (adhesion loss).Although the major function of sway brace assembly 1422 can be to every Individual substrate 1402,1404 applies tension force to keep otch I to close, but in many embodiments, sway brace assembly 1422 It can be also used for providing column intensity, make pair from the distraction force that may upset notching edge alignment and pairing will pass through Otch I compression (or the bending along otch I or fold) minimizes and isolates otch I.Enough axial directions can be directed to curved Bent flexible and transverse compression and bent support and the axial spacing, material character and the size that optimize sway brace 1422.Excellent Select in embodiment, the spacing between tie-rod 1422 is 10mm, and the material of tie-rod 1422 is nylon, and size is 0.030 English Very little circular section.

With reference to Figure 14 B, base portion assembly 1400b can be placed on the skin in the joint (such as knee) of patient or subject In otch on.In place of the joint close to motion, in the otch placed especially proximate to knee, closing device or closure apparatus Integrality suffers from the challenge of many factors.These factors include：When occurring joint motions, the longitudinal direction of wound extends, circumferentially Swelling, opening；The skin injuries such as foaming；Adhesion loss；And the discharge of wound fluid.Such as knee, ancon, pin The joint such as ankle and shoulder may undergo movement, and this there may come a time when to cause to cover the joint motions mobile more than 135 °, so as to cause Above-mentioned challenge.

Skin around bending position, knee may axially (that is, parallel to otch) and laterally (that is, transverse to or it is vertical Directly in otch) stretching up to 50%.The cut closure apparatus of the skin adhered in the region can be preferably able to provide foot Enough tension force carrys out close incisions, but stretching is adapted to minimum local stress.Minimize local stress is set to prevent office Portion's skin adhesion loss or the damage in the case where not occurring adhesion loss to skin.Many otch disclosed herein The critical nature of closure apparatus is the tension load of the closure member of apparatus being distributed in than tension element attachment point itself more Ability on big area.In addition, the structure including the adhesive attached by the element of tensioning 2 can have in many cases The ability of the compliance of the structure is distributed on the region of skin stretch so that apparatus is when skin is moved around it by otch Keep in situ.Embodiments described herein can include compound the setting of non-stretching tension element (commonly referred to as " band ") Meter, the non-stretching tension element links to " lock " for being held in place band.For example, this class component can include it is described above Sway brace assembly 128,140 and 1422.These elements may be mounted at the adhering skin of flexible polymeric material In agent, the elastic polymer material helps to be distributed tension load.In many cases, such elastomeric polymer can bent Clothes or permanent deformation before have high elongation rate, and can including polyurethane etc. thermoplastic elastomer (TPE) and various grades Silicone.Such material can also be easily formed film necessary to the compliance for keeping slim and enough.

The surgical appliance adhesive used in apparatus may also need to bear the elongation of skin, and can recover in skin to Retract/rebound during unstretched state (for example, in knee position of full extension).Hydrocolloid adhesives can provide such property Matter, and preferably it is suitable for such application.Other adhesives such as acrylic acid can also be used to provide this property Matter.In general, such adhesive may need to be attached to all elastic films as above, so as in expansion and Its structure is kept in rebound process.If without such support, adhesive tears and separated such as cyclic extension.

A series of cut closure apparatus for being built as short segments can be in the situation without adhesion loss or skin injury It is lower to adapt to higher percentage of total elongation.Each individually section can suffer from the local elongation of skin under it.Two phases Space between adjacent section can serve as stress elimination space, so as to allow skin to stretch within this space.Segmentation can be with more Kind of mode is realized：(1) by allowing device when it is applied to skin along the single section of cut line laying, or (2) Or applied to being divided into short segment after skin.

The preferred embodiment of segmentation is realized after applied to skin to be included as described above in layer of polyurethane (that is, substrate 1402nd, 1404 upper strata 1406,1410) middle creation perforation (for example, horizontal line of perforation, to promote tear), and keep following Adhesive is perfect, as shown in Figure 14 B.Perforation can its with knee flexion (that is, carry out joint motions) through tension Cause tear of at least upper strata (for example, upper strata 1406,1410) of substrate along perforation line (for example, line 1424,1426) when stretching. In a preferred embodiment, adhesion sheet of the otch per side can be that 12mm is wide, and the punched interval in given plate Open about 12-20mm.Test and prove, the perforation of 3mm otch and 1mm tie-rods in knee flexion for realizing Segmentation in the urethane substrate of 0.001 inch is effective.With the flexing of knee, skin may be in some positions along axle To (along otch) and horizontal direction elongation up to 50%.Therefore, the separation of polyurethane can mitigate when device is through Tensile Stress in device.

As an example, the knee through surgical repair may the inflammation within a couple of days, this may cause joint big after closure About 30% radial direction swelling.Elastomeric material such as polyurethane etc can allow cut closure apparatus (e.g., including to adhere to figure The otch I formed in 14B base portion assembly 1400b) expanded with such circumferential swelling.Minimize the width of apparatus (for example, each substrate section 1402,1404 is 12mm or less) can make what apparatus was subjected on the direction perpendicular to otch I Amount of expansion is minimized, and therefore can keep adhesion while the possibility minimum of skin injury is made.Figure 14 B are shown The perforation in section is adhered to, the perforation extends to otch along line 1424,1426 in a lateral direction, easier to allow Axial tension.Perforation can also be made parallel to otch in the outer edge close to adhesion section or other open a window, to reduce As skin radially outward stretches stress caused by (such as during joint motions and swelling) from otch.

With reference to Figure 15 A- Figure 15 D, the tendency that otch may be often subject to the flexing due to knee or other joints and cause In beating scalloping power.In many embodiments, cut closure apparatus possesses retaining mechanism, and the retaining mechanism passes through in flexing During close to resist tensile force, to assist in keeping cut closure.Figure 15 A and Figure 15 B show cut closure apparatus Base portion assembly 1500, its using pulley effect mechanism, i.e. when skin is along lancing-drawing, otch either side The distance between locking point shortens.In a preferred embodiment, substrate is to the viscous of every side of the otch between 1510a, 1510b Attached plate 1510a, 1510b is that 12mm is wide, and the perforation 1530 into line in given plate 1510 is spaced apart about 18mm.It is logical Often, all components of retaining mechanism are non-stretching formula.As shown in Figure 15 C, by anchoring piece 1540, pulley 1520, lock 1550 With flexible locking element 1580 (for example, tethers or band) formation triangle have axially along otch base B and Laterally across the height H of otch.With knee flexion, the increase of triangle base length.Generally, all components of triangle are Non-stretching formula, this requires that height must reduce to remain attached to the length of the discrete component between any two points, so as to produce The raw additional closing force across otch.The lower surface that Figure 15 A and Figure 15 B also show substrate 1510a, 1510b can include glue Body adhesive 1560, and one of plate 1510a or 1510b can include locking arm 1570, for band 1580 to be locked to Position.Although showing that the base of triangle is located on left substrate 1510b in Figure 15 A, it is contemplated that the base of triangle can be with It is alternatively positioned on right substrate 1510a.

Although forming triangle by anchoring piece 1540, pulley 1520, lock 1550 and flexible locking element 1580, it is also possible to It is susceptible to other shapes.For example, pulley 1520 can be wrapped in around two anchoring pieces 1540 to form square or rectangle shape Shape, or pulley 1520 can be wrapped in around three or more anchoring pieces 1540 to form trapezoidal shape.With reference to Figure 15 D, The base portion assembly 1500a of cut closure apparatus is shown in figure, it is similar to base portion assembly 1500.In substrate 1500a, Anchoring piece 1540, two pulleys 1520, lock 1530 and the formation rectangle of flexible locking element 1580 are with following skin stretch When additional closure is provided at otch I.In rectangular arrangement shown in Figure 15 D, the two fixing points of otch I either sides it Between spacing generally would is that identical.And in the triangular arrangement shown in Figure 15 A and Figure 15 C, pulley 1520 side is consolidated Fixed point can be spaced apart farther than otch I opposite sides., can be with although rectangle is shown as " opening wide " on left substrate 1510b It is contemplated that the rectangle can alternatively " unlimited " on right substrate 1510a.

Cut closure apparatus base portion assembly 1400a, 1400b and 1400c and sheet shown in Figure 14 A1- Figure 14 A3 In other cut closure apparatus base portion assemblies described by text, single band 1422 can be used to engage positioned at otch I's The single lock of opposite side.In Figure 15 A- Figure 15 D, each flexible locking element or band 1580 are generally anchored in the one of otch I Side, is wrapped in around opposite side, and then engagement is located at the lock 1550 with the position identical otch I sides of anchoring piece 1540. In the embodiment shown in Figure 15 D, flexible locking element or band 1580 are twined in engagement before the lock 1550 of the same side Around two fixing spools (spool/pulley 1520) for being wound on otch I opposite side.Flexible band 1580 is wrapped in volume thereon Axle 1520 preferably can be coupled with rigid member so that the distance between they are in the piece installing 1500 of closing device substrate in batch in axle Do not increase when being protruded upward to side.In the alternative, it may be desirable to allow the expansion between pulley or spool 1520. It should be noted that flexible locking element 1580 can be anchored in a substrate section, at the same be locked in by substrate 1510a or In the adjacent segment that perforation 1530 in 1510b is separated.Such anchoring and locking can be in three sections of base portion band Connection is created between (two sections are located at the same side, and a section is located at opposite side).When across Tncision closing device or base When portion's assembly 1500 or 1500a length consider in the lump, it is (that is, snakelike) even that across the otch I of attachment means forms continuous serpentine Connect.

The flexible connector 1580 for the tensioning being wrapped in around heart axle, spool or pulley 1520 can be arranged in stretching Power attempts to open otch and following skin is through providing the additional compression to otch I during Tensile.In some cases, if The external force that two substrate 1510a are got together further is compressed, then flexible band 1580 may be slided potentially from heart axle 1520 Take off and fluff, any stretching without causing following skin.In order to prevent such slippage, flexibility winding component 1580 It can be slidably received in or be anchored in and anchor in the element 1590 on base portion band 1510a.Figure 15 E and Figure 15 F are shown Pass through the flexible member 1580 of pipe 1590, the pipe 1590 then be attached to or be anchored to substrate 1510a.When substrate 1510a, When 1510b is gathered together closer to ground, flexible taped components 1580 will still be captured, and offer is provided must The closure function wanted.In other embodiments, the spool feature 1590 shown in Figure 15 E and Figure 15 F can have through center Hole, the hole is slid through by band 1590.Flexible band 1580 and its element 1590 slid through are preferably set Counting into makes the minimum friction forces between element 1580 and element 1590.

Carried out test and prove, on base B be 12mm, and after cut closure by two substrate 1510a, In the case that the distance between band tie point on 1510b determines height H (normally about 16mm), the device on human knee The flexing of tool 1500 causes height H to reduce 5% in the maximum region of wherein skin S elongation.It should be noted that the reduction of height It is likely to be dependent on Multiple factors, two bases on the base of such as triangle, the elongation degree of lower surface skin and otch either side The distance between portion.Connection " band " between anchoring piece 1540 and lock 1550 may need it is at least partly flexible, To allow around pulley circulation.In a preferred embodiment, by monofilament plastics silk thread with engaging the feature phase in retaining mechanism It is integrated.Such feature can be the circle " tooth " in the ratch shape mechanism being engaged in lock.Such plastics can be used for obtaining Desired flexible, longitudinal hardness, low Carried bacteria tendency are obtained, and allows extrusion and/or injection molding technique.It can also use Braided suture (preferably having coating to be carried with restricting bacterial) creates flexible and non-stretchable connector.It can also use The circle silk or pipe that are made up of flexible materials such as silicone obtains flexibility.The band of pulley can be such as moulded plastic With the compound of the material such as braided suture.In other embodiments, the band of pulley can by making molding band constriction and Formed.Molding band is drawn to can for good and all reduce the cross section of band beyond its yield point, and make it in elongation It is more flexible.Heat can be used in necking process to promote the reduction of elongation and cross-sectional area.Figure 16 A- can be used to scheme Alternate mechanism shown in 16B, so as to once lock band material in the case of realizing desired closure, such as suture and compared with Soft plastics.Figure 16 A show retaining mechanism, and it includes the groove 1610 and anchoring frame 1620 for sliding.Figure 16 B show lock Tight mechanism, it includes locking teeth 1630.Figure 16 C show retaining mechanism, and it includes the groove 1640 and anchoring frame for sliding 1650.Figure 16 D show retaining mechanism, and it includes cylindrical tube 1660 and locking teeth 1670.

It can be obtained in knee flexion and be closed across the additional of otch by using linkwork 1700 as shown in Figure 17 With joint efforts.As shown in Figure 17, can with the non-stretching arm 1730 of X-shaped by four points of otch either side (cut closure apparatus Two anchor points 1720 on per side or substrate 1710) connect, and provide and be hinged at crosspoint 1740.With knee The distance between two points of the same side of flexing and otch increase, and the distance between section of either side of otch can subtract It is small, so as to produce additional closing force.As shown in Figure 17, substrate 1710 can also possess multiple perforation 1750 to promote to substrate 1710 axial tension, or promote its vertical section of separated component in axial tension.

As shown in Figure 18, according to many embodiments, the band and lock of cut closure apparatus 1800 can be arranged to The S-shaped or snakelike connection or arrangement of the whole length for the otch I being formed across on the skin S of knee.Cut closure apparatus 1800 Can cut closure apparatus 1400 similarly as described above in many aspects.By by each section 1810a of otch I side Connected with two adjacent segment 1810b of the opposite side of otch and make section 1810a, 1810b of device 1800 phase each other Even.This can be by installing a pair of bands 1820 and being installed on the corresponding section 1810b of opposite side in each section 1810a A pair of locks 1830 are realized.Each pair lock 1830 and band 1820 can be connected with each other.In wound or otch I closing course, base One of plate segment 1810a (for example, 1810a1) band 1820 (for example, band 1820a) can be with otch I opposite side section Lock 1830 in section 1810b (for example, 1810b1) is connected, and the second band 1820 (for example, band 1820b) can with adjacent to The section 1810b (for example, 1810b1) of the band 1820 (for example, band 1820a) being previously paired, otch I are connected wherein Opposite side section 1810 (for example, section 1810b2) in lock 1830 (for example, 1830b) be connected.It is above-mentioned to constitute Substrate section 1810, band 1820 and lock 1830 S-shaped or snakelike arrangement it is monocyclic.Perforation line 1850 can separate axially adjacent Substrate section 1810a and 1810b.The perforation line 1850 (for example, with substrate section 1810a) of side can be worn with opposite side Hole line 1850 (for example, with substrate section 1810b) interlocks.Similar to Figure 15 A, in a preferred embodiment, positioned at otch Adhesion sheet per side can be that 12mm is wide, and the perforation in given plate can be spaced apart about 18mm.

Cut closure apparatus or device as described herein can be applied in many ways.Figure 19 is shown according to some realities Apply the exemplary cut closure apparatus 190 of mode.Here it is possible to single base portion arranged in pairs is provided in section 1910 single On carrier/release liner.Each pair substrate section 1910 includes band 1920 and lock 1930, and the band 1920 and lock 1930 can be with Independently adhere to cut alignment and adjacent to each other skin.Release liner and outer belt carrier 1950 can be used by single section 1910 keep together relative to each other.Release liner 1950 can be removed to expose adhesive, but whole device 1900 or dress Putting 1900 packet partial can be coupled with outer belt carrier.When applied to skin, belt carrier 1950 can be removed, so as to leave viscous Attached section 1910, the adhesion section 1910 is aligned with each other but can independently move.

The perforation section (generally comprising polyurethane) on substrate upper strata (can generally comprise water by one layer of continuous adhesion sublayer Colloidal adhesive) keep together, to allow to be laid in a continuous motion on skin.Figure 14 A- Figure 14 B, Figure 15 A- Figure 15 C and Figure 18 cut closure apparatus 1400,1500 and 1800 can possess such continuous adhesion sublayer respectively.

The base portion assembly or substrate of cut closure apparatus as described herein can be in the ends of wound or cut closure by soft Property adhesion membrane material covered.The diaphragm area preferably may be larger than base portion cut closure panel element, so that it makes the element It is overlapped on skin.The film can help to prevent the migration of base portion, and can prevent any of anchoring piece and retaining mechanism Accidental movement.The cover layer can be made up of Stretch materials such as rubber, latex, polyurethane, silicone or thermoplastic elastomer (TPE)s. In a preferred embodiment, thin covering (for example, layered product of 0.001 " urethane and 0.002 " thick acryloid cement) will There can be the compliance bigger than the composite construction of base component.Therefore, covering can be in exposed skin and base segment Between some strain reliefs are provided.Covering can also be transparent, to allow the visual inspection to otch.Covering can be across Otch is fully sealed (for example, as barrier to infection), or can have the opening being aligned with cut line on covering, with Allow passing through for any diffusate from wound.Covering can be additionally used in by bridging substrate and adhering between base portion band Skin edge improve the pairing of notching edge.Covering can be also built into additional fastening element, described additional Fastening element improve base component between tensile strength, but allow along incision length compliance.Preferred embodiment A series of polyethylene glue tapes applied to covering can be included.

, can it is contemplated that arriving although user applies covering after being placed in base portion assembly and plate on skin To supply " skirt section " of the covering material as extending around the outer perimeter of base segment.Therefore, covering material is relative to base portion Alignment can be independent of user placement.These identical covering materials can provide following effect：Prevent hydrocolloid Adhesive is exposed to patient garments, the migration of limitation hydrocolloid or other adhesion lower floors, offer to the tension force on base segment Strain relief etc..

In many embodiments, hydrocolloid adhesives are used for for cut closure tensioning skin.Can be by following One or more of mode prevent the creep of hydrocolloid：(1) creep, or (2) are limited using layered product on the surface Adhere to covering to prevent creep and provide strain relief to skin to prevent skin from damaging across skin and hydrocolloid adhesives application Wound.

In many embodiments, one in may include to perforate or be open with the covering that base portion assembly is used together Or it is multiple, to allow to remove wound fluid (and any application in the case of the base portion assembly without removing adhesion Bandage/absorbing material).

In many embodiments, the covering includes the compound of flexible urethane and reinforcing strip band.Compound structure can To provide the intensity across otch, and provide the compliance along incision length.

In many embodiments, make in the axial direction with horizontal direction with the covering that base portion assembly is combined Skin incision edge is aligned or significantly prevents subsequent skin edge from misplacing.

In many embodiments there is provided cover gasket configuration, so as to first to the one of dermal application covering Part, this then helps the removal that other are padded, and therefore can help to control thin material so that it is equal with minimum fold Lay evenly.

In many embodiments, the removal of the first pad can allow the visualization in placement process, and can be with The remainder of anti-locking apparatus clings user.

Referring again to Fig. 9 and Figure 10, in many preferred embodiments, two adhesion sheets 104,106 are applied to surgery The either side of otch (before or after otch is made).Close mechanism may be mounted on adhesion sheet 104,106, and can Component 120 is preferably attached to, the component 120 helps to be distributed closing force between the attachment point of close mechanism.Such as Fig. 9 and figure Shown in 10 and Figure 20 A and Figure 20 B, the close mechanism may include band 130 and lock 132.Band 130 may include there is engagement The elongated member of tooth.Lock 132 may include the feature of the soldered tooth for catching band 130.Band 130 can be tensed in lock 132 In, so as to which adhesion sheet 104,106 (and so as to by notching edge) is pulled together.When necessary, user can disengage and The band 130 in lock 132 is re-engaged, suitably to adjust the amount of skin closure.Meanwhile, the cut closure illustrated in Figure 20 A Apparatus can be described as base portion or base portion assembly 102.

Surgical appliance adhesive for each plate 104,106 preferably includes hydrocolloid adhesives.Alternatively or in combination, Surgical appliance adhesive may include one of many propylene acid supplements known in the art.Hydrocolloid adhesives can have very glue and The benefit of moisture and exuviae skin cell can be absorbed.Therefore, hydrocolloid adhesives can be particularly suitable for long periods of wear apparatus (for example, up to 14 days).However, at least some cases, hydrocolloid structure is probably soft, and easily under tension Generation creep, unless reinforced in some manner, such as by using other coverings of harder substrate 120,104 or disclosed herein Structure covers hydrocolloid adhesion layer.

Correspondingly, another aspect of the present invention additionally provides the base portion for reinforcing and protecting cut closure apparatus as described herein The various means of adhesion layer in assembly, and the additional of (particularly in the axial direction) that skin edge kept together Means.In at least some cases, single hydrocolloid adhesives have low-down tensile strength, and may need reinforcement Means are to prevent it from tearing in use or creep.As shown in Figure 21, the adhesion layer used in substrate 104,106 211 can mutually be laminated with compliance plastics or polymer 212 (such as urethane) thin layer, and the compliance plastics or polymer 212 are thin Layer is preferably 0.001 inch, and potential scope is up to 0.010 " thick, may assist in during Clinical practice and keeps it to tie Structure.Adhesion layer can be nominally 0.010 inch in itself, but can be between 0.005 inch and the scope of 0.020 inch.By Adhesion arrangement 211 may be attached in the tensioning element of band 130 or lock 132 including being attached to power load distributing component 118 Top, therefore there is a possibility that material can creep over time.Layered product 212 and positioned at adhesion layer 211 with it is negative Any other adhesion layered product 215a, 215b between lotus distribution component 118 can help to provide to prevent adhesion layer creep Structure.

As shown in FIG. 22 A, in order to further prevent the migration of adhesion sheet 211, it can also apply and cover on plate 104,106 Cover material 220.As shown in Figure 22 B, covering 220 can include compliance elastomer 221 that is thin, scribbling adhesive.Permitted In many embodiments, it (is preferably 0.002 English that covering 220, which also includes scribbling the surgical appliance adhesives such as acryloid cement, Very little thickness) thin urethane layer (be preferably 0.001 inch), it may be provided on one or more release liner 223a, 223b. Covering may also include reinforcing feature 225.

As shown in Figure 23 A and Figure 23 B, covering 220 can be constructed so that its it is extensible beyond substrate 104, 106, so as to bridge skin S and plate 104, the distance between 106 d3.Typical minimum can must be 8mm apart from d3, but can be with In the range of 2-15mm.In addition to helping prevent the adhesion layer creep of substrate 104,106, the urethane skin of covering 220 Adhesive also assists in the tension force progress strain relief that substrate 104,106 is applied to the movement by surrounding skin S.This can be used In prevent substrate 104,106 edges skin injury (for example, rotten to the corn or foaming).It should be noted, however, that due to hydrocolloid certainly Body can move with skin S and thereby resist the damage to skin S, and the compliance property of hydrocolloid provides the part for foaming Protection.In many embodiments, even if there is the harder structure for the outer surface for being attached to adhesion layer, lower to skin surface Compliance in 0.010 " nominal thickness of adhesion layer stills provide the resistance to skin injury.

Except board structure is stabilized and strain relief in addition to, covering 220 can be used for other purposes.Pass through covering Band 130 will engage the position of lock 132, and covering 220 can prevent patient from will lock 132 plays and may be disengaged to band 130 Degree.As shown in Figure 23 A- Figure 23 C, covering 220 can be equipped with opening along the length in the region overlapping with otch 224th, 224 ' so that the gauze that outside applies can be with absorbing wound exudate.In other embodiments, covering 220 can be with Without opening, to protect the wound from the evil of the source of infection.Covering 220 itself can have reinforce feature 225,225 ' with to Base portion 102 is provided in the additional resistance power opened for otch, the particularly region between band 130.Figure 23 C show spy Embodiment is determined, wherein it can be rectangle article tape to reinforce feature 225 '.Preferably, perpendicular to skin incision, adhesive tape 225 ' can It is harder with the compliance urethane layer 221 than surrounding.Adhesive tape 225 ' can be built-up by any combination of the following：Scribble bonding Woven fabric, polymer fiber, polyethylene, polypropylene, nylon, PET, hydrocolloid or the other materials known in the art of agent. Reinforce feature 225 ' can also increase " body " or rigidity to covering 220, to help it to place.Urethane layer 210 can be by this class material Material is built-up, to give its biaxial tension.

The spacing of feature 225,225 ' is reinforced for ensuring longitudinal direction (parallel to cut line) compliance (example of covering 200 Such as, due to the thin urethane of compliance) it is probably important.This can be used for by allowing covering 220 and following base portion group Piece installing 102 is moved with the motion of body, to improve the comfort level and the resistance for skin injury of patient.The effect can Covering 220 can be individually come from, or is used as the compound effect with the feature for allowing longitudinal compliance of base portion assembly 102 Really.Reinforcing member 225,225 ' can also be uniform construction, but perforated, slotted or otherwise mechanically interrupted, to permit Perhaps with the stretching and/or controlled tear of body kinematics.One or more thin urethanes of covering 220 can also mechanically be interrupted Layer is to realize identical effect.In at least some cases, the reinforcing feature 225,225 ' of covering 220 can not be extended over The whole width of thing 220 (perpendicular to otch).This limited cover width can help to ensure that for perpendicular to the remote of otch I From the strain relief of the body kinematics of base portion assembly 102.In a preferred embodiment, reinforced by strenthening member 225,225 ' The region of covering 220 upwardly extends 10mm in each side away from notching edge, but this can be in the range of 2-50mm.

Another feature of covering 220 can increase the control for notching edge, particularly in base portion assembling Between the tensioning element 130,132 of part.As shown in fig. 24 a, can with the tensioning element 130,132 that substrate 104,106 is combined For making notching edge 205 close to together.Once skin S is approached, and skin edge is vertical (perpendicular to skin surface) Alignment is probably important.Vertical dislocation may cause healing slower, and visible " sublevel " or rib ridge in otch, and this may Cause bad scar aesthetic property.By the way that some parts of covering 220 are attached into the every of substrate 104,106 along otch Individual edge, can make each edge keep perpendicular alignmnet under tension as shown in arrow 201a, 201b.Across otch I covering Adhesive on the part of thing 220 can also be directly attached to skin S at notching edge, so as to further shorten cutting of being bonded The distance between mouth edge simultaneously further enhances vertical skin alignment.As shown in figure 23 c, in a preferred embodiment, across The part of otch I covering 220 is rectangle article tape 225 '.Axial direction between the width and band 225 ' of each band 225 ' Gap can be optimized for the effusion of notching edge control, otch visibility and wound fluid.Preferred embodiment Wide and interval 6mm the bands of 12mm can be included, and band is located between each band.It is contemplated that to other width and Away from.By not bridge joint/covering on each band 130, band 225 can more flat against skin S, preferably viscous to obtain Echo Edge position control.

In some embodiments, reinforcing feature 225,225 ' can be constructed to be limited in the bending at cutting part Amount.In these embodiments, reinforcing feature 225,225 ' can be harder than skin S, and preferably than substrate 104,106 Surrounding component is harder.In this way it is possible to isolate caused by normal patient motion to the skin S around cutting part Bending or compression, or limit its propagation.The motion isolation of even now or limitation will may consequently contribute to strengthen cutting under tension force Oral area position, but bigger benefit can be to prevent notching edge significantly or unevenly varus, turn up or perpendicular to skin The square upward displacement on skin surface.Reinforcement material as discussed above can be used, and adjusts thickness, it is desired firm to create Degree.Preferably, the compound of base portion assembly 102 and covering 220 can be built, so as to create rigidity seamlessly transit and From surrounding skin to the compliance of segregate cutting part.

In specific application method, realizing the first closure of otch so that skin edge connects using base portion assembly 102 After near, further substrate 104,106 can be pushed together, so as to the otch I of upward " pushing " closure, so that edge is somewhat The skin S around notching edge is turned up and/or compresses to discharge tension force.Figure 25 A- Figure 25 C illustrate this method group in vivo Embodiment in organization model.Figure 25 A show step 250A, wherein adhere to substrate 104,106 adjacent with otch I Skin S, and they are pushed together with the otch I of upward " pushing " closure.Then further substrate 104,106 can be drawn Together, tissue is maintained in this orientation.By the way that substrate 104,106 is remotely located from notching edge 5-10mm, These methods can be strengthened.In the step 250B shown in Figure 25 B, with band 130 and 132 can be locked by substrate 104,106 phases It is in place for being locked to each other.In the step 250C shown in Figure 25 C, then can using covering 220 come lock substrate 104, 106 and " pushing " otch I relative position.It can be cut with fastening element 225,225 ' as discussed above further to reinforce Mouth I.

In many embodiments, given covering 220 can help user to cover equipped with release liner Thing 220 is applied to handle covering 220 before patient and during application.As shown in Figure 22 A and Figure 22 B, covering 220 can be with With release liner 223a, 223b that application is configured with three parts.User can remove longitudinal center pad 223b first, with The adhesive that center exposes is applied to base portion assembly 102 and skin incision region.Pad 223b removal first, with reference to By the transparent plastic in the center of base portion 220 or the visualization of opening, user can be allowed to see the base portion assembling of lower section Part 102, so that can be appropriately aligned covering 220 with base portion assembly 102 in application covering 220.This is also The region for the covering 220 not adhered to user can be helped to provide, until covering 220 is initially fastened to base portion assembling Part 102 and/or skin S.Next, side release liner 223a can be removed on the direction perpendicular to otch I.Pad 223a Keep and tensioning very thin urethane, with keep its when applied to skin S it is substantially wrinkle resistant.In addition, by that will cover first The center of cover material 220 is pasted on base portion assembly 102 and/or skin S, can be held in place covering 220, so as to Apply enough tension force and control to side release liner 223a, for the remainder of the covering 220 that scribbles thin adhesive To the smooth application of patient.Alternatively or in combination, can by pad structure into the first pad is removed with exposure covering Narrow strips (perpendicular to otch I) on the whole width of thing 220, to allow on base portion assembly 102 and/or skin S Initial placement, then removes one or two additional pad on the direction parallel to otch I.First pad can be located at length Centre, either end, or fall between.If not being located at end, two added with padding may be needed, each lining Pad and be removed in the length outwardly direction from the first position padded along device.If the first pad is located at an end End, the then end that can be outwardly directed to device from the position of the first pad removes the second single pad.

Another release liner configuration can be that, with single pad, the single pad can be before application from covering 220 Bottom remove completely.Such pad may need outer membrane or casting piece, and outer membrane or the casting piece is lightly adhered to To the outer surface of covering 220 to help thin urethane to keep its shape, and provided to user in side and/or end not Therefore the position of user on hand is not sticked to adhesive and in application process.Outer membrane can be in whole outer surface On, or be only in the specific width around the circumference of covering 220.The film and/or release liner, which can also have, to be prolonged Stretch the region of the thin urethane in covering 220.Once covering adhesive is attached to base portion assembly 102 or skin S, just Easily casting piece can be removed from the outside of covering 220.

As described herein, flexible wound dressing and wound or Tncision closing device or apparatus are typically flexible and can drawn Stretch, with follow the bent portion (for example, arm, curved longer otch etc.) of body or through Tensile region (for example, Knee) profile.In order to aid in the drape of such device, the back of the body for helping that dressing shape is kept in application process can be used Lining material.Such interim back lining materials as described herein can have multiple advantages.Back lining materials can be transparent with support pair Wound is checked.The material can be non-stretchable, to prevent dressing or closing device or apparatus in application process Elongation.Backing can be easily removed after the application of wound dressing or closing device or apparatus, so as not to influence reality Adhesion of the dressing in wound location.Back lining materials may also help in processing in the fabrication process to dressing.Implement many In mode, back lining materials can be coupled to dressing or closing device with the ripping type release liner of the adhesion side of dressing, to support Back lining materials simple and reliably remove.

With reference to Figure 26 A, wound dressing covering 2600 may include to be made up of flexible materials such as rubber, urethane, silicone Flexible sheets 2610.It is casting piece or the relatively harder material of carrier layer 2620 that flexible material 2610, which can be layered in form, On.Casting piece 2620 prevents flexible material volume 2610 to itself and becomes to use.Flexible sheets 2610 can side (for example, Bottom side) there is adhesive and there is relatively hard (hard) carrier layer or casting piece 2620 in opposite side.Adhesive side Protected by two pads 2630,2640, described two pads 2630,2640 can be removed successively, so that in a controlled manner Expose adhesive.In order to which dressing 2600 is applied on wound or otch, by removing one of described release liner, generally Less release liner 2630 is removed, to expose a small bar adhesive.The release liner 2630 can use adhesive tape 2650 attached It is connected to casting piece 2620.The expose portion of flexible sheets 2610 can then be adhered to one end of wound or otch.With second Release liner 2640 is removed continuously to expose adhesive by slow, flexible covers 2600 then follow wound or otch with And the profile of the bending on body.

Then it can use and the first release liner 2630 of casting piece 2620 is generally still attached to adhesive tape 2650 come from soft Property dressing 2610 lifts casting piece 2620.

The manufacturing process of wound dressing covering 2600 and associated cushion 2630,2640 can be cut using single matrix Cut out the layered product of release liner 2630, release liner 2640, flexible dressing 2610 (carrying adhesive) and casting piece 2620 Common profile (circumference).After removal pad 2630,2640 and by the application of dressing sheet 2610 to skin, casting piece 2620 can be protected Stay in dressing sheet 2610.The removal of casting piece 2620 may be needed by making the edge of casting piece 2620 from 2610 points of dressing sheet Layer simultaneously is peeled off to trigger.Once having triggered, then it can be simple direct that the continuation of casting piece 2620, which is peeled off and removed,. The initiation at the edge of casting piece 2620 and lift and not always intuitively, and may may need to be connected to casting piece 2620 Free edge lifts a little to help to recognize and starts to peel off.Adhesive tape 2650 can be used for casting piece 2620 bridging to release liner 2630, and readily identified auricle can be provided, the auricle, which can be used for triggering, to be peeled off.

As shown in Figure 26 B- Figure 26 E, the alternative configurations of casting piece 2620 can be used to trigger the stripping of casting piece 2620 From.

As shown in Figure 26 B, casting piece matrix can be cut, is applied with causing casting piece 2620a axially extending beyond flexible Tablet 2610 is (for example, can be by the pad 2630,2640 and urethane material " osculating " of flexible dressing sheet 2610 to casting piece 2620a surface).

As shown in Figure 26 C, casting piece 2620 can have adhesive tape 2650, the adhesive tape 2650 be applied to either axial side side or Whole two axial sides, to extend beyond casting piece.Adhesive tape 2650 may not necessarily be attached to release liner 2630.

As shown in Figure 26 D, casting piece adhesive tape 2650 is attached at one or more axial edges of casting piece 2620 Or near it, and extend also in the profile of casting piece 2620, the non-stick attachment edge 2652 with release is grabbed for user Hold.

, can be from an axial edge of casting piece 2620 to the part of another axial edge or complete as shown in Figure 26 E Cutting casting piece matrix is (for example, carry out osculating so that casting piece 2620 is not cut flexible dressing sheet 2610 over long distances In).The casting piece 2620 cut out can be separated by " nip " of user, to create the edge for grasping.As schemed Shown in 26E, internal matrix cut edge can also have the adhesive tape or similar applied to one or both internal edge Auricle 2654 for grasping and peel off.

In many embodiments, casting piece 2620,2620a and/or adhesive tape 2650,2652,2654 can be different face Color, or with mark, to be different from flexible dressing sheet 2610 and release liner 2630,2640.

The one or more assemblies of cut closure apparatus disclosed herein or cut closure apparatus assembly, including it is various Base portion assembly, substrate, power distributed architecture, axial support, horizontal support piece, closing assembly, tie-rod assembly, band, lock, Adhesion layer, adhesion layer, covering, blanket structure, drop cloth etc. one or more of including, can include, scribble or with Other modes are incorporated to the one or more in the following：Anti-mycotic material, anti microbial materials, antimicrobial material, preserving timber Material or medicinal materials.For example, such material can be incorporated into hydrocolloid adhesion layer, as another between skin and adhesion layer Layer or the coating at least a portion of adhesion layer (covering), be incorporated into base portion assembly covering or at least its adhesion layer, etc.. It is such to promote that one or more holes, groove, opening, hole or similar structure can be provided on device or apparatus assembly It is incorporated to.In many embodiments, such material can include the natural material such as silver, iodide, zinc, chlorine, copper or tea oil One or more in material are used as activating agent.Such anti-mycotic material, anti microbial materials, antimicrobial material, anti-corrosion material or The example of medicinal materials includes but is not limited to the Acticoat that can be bought from the Smith＆Nephew plc of Britain^TMSeries material, It can be bought from the Smith＆Nephew plc of BritainHumid control series material, can be from Denmark Coloplast A/S are boughtFoam series material, can be (French from the Urgo Limited of Britain Laboratoires URGO subsidiary) buySilver-colored series material, can be from the Smith＆Nephew of Britain What plc was boughtHydrocolloid series material, it can be bought from New Jersey Skillman ConvaTec Inc.Ag series materials, can from Texas San Antonio Kinetic Concepts, what Inc. was boughtSeries material, can from Texas San Antonio Kinetic Concepts, what Inc. was boughtSilver 220, can be from the Urgo Limited (French Laboratoires URGO subsidiary) of Britain BuySSD series materials, can be from Texas San Antonio Kinetic Concepts, Inc. BuySeries material, the that can be bought from the Smith＆Nephew plc of BritainSerial material Material, the Sorbsan Silver that can be bought from the Aspen Medical Europe Ltd. of Britain^TMSeries material, can be from Erie The Polymem that noy state Burr Ridge Ferris Mfg.Corp. are boughtSeries material, can be from Texas State San Antonio Kinetic Concepts, the Promogram that Inc. is bought^TMSeries material, can be from Texas San Antonio Kinetic Concepts, the Promogram Prisma that Inc. is bought^TMSeries material and can be from her What sharp noy state Mundelein Medline Industries were boughtSeries material.In jointly owned U.S. State's patent No. 8,313,508,8,323,313 and 8,439,945；U.S. Patent Publication No. 2013/0066365；And PCT application In number US 2010/000430, US 2011/139912, US 2011/40213, US 2011/34649 and US 2013/067024 The component of the closing device of description can also include, scribbles or otherwise be incorporated to anti-mycotic material, anti microbial materials, resist micro- life One kind in one or more in thing material, anti-corrosion material or medicinal materials, material including but not limited to listed above or It is a variety of.

In many embodiments, it is directly incorporated into topical pharmaceutical formulation into wound closure apparatus as described herein.Due to Wound closure devices be often applied to close to need medicament protection wound or otch in place of, thus such medicine to closure fill Being directly incorporated into putting is probably beneficial.For example, in having the wound of infection risk, being incorporated to for Antimicrobial agent is probably Beneficial.Antimicrobial agent may include antimicrobial agents and non-corrosive metal (NCM) ion and the compound associated, and this can be wrapped Include the natural materials such as silver, iodine, copper and chlorine or tea oil.For example, in easily fungi-infected wound, can be approved to make With pharmaceutical preparations such as zinc.The combination of any medicament in these medicaments is also likely to be beneficial, and therefore can be incorporated to Into wound closure apparatus.

Topical pharmaceutical formulation can be incorporated into closing device in this way：Giving closing device is keeping wound to fill Diffusate is wicked out into wound while aqueous enough (to leave wound for example, guiding undesirable organism and/or prevent skin Dipping) to improve the ability of healing.

With reference to Figure 27 A, wound or cut closure apparatus 2700 include base portion, the base portion include two substrate 2710R, 2710L, described two substrate 2710R, 2710L include upper polymeric layer 2720R, 2720L and applied to close to surgical incision I Every side in place of lower adhesion layer 2730R, 2730L.The features such as plate 2710R, 2710L band 2740 can allow more The skin of otch I either side is pulled together during conjunction and keeps in situ.Adhesive preferably includes glue body preparation, but Also it may include acrylic acid or other adhesives as known in the art.Upper polymeric layer 2710R, 2710L are (for example, 1 Mill (mil) polyurethane) adhesion layer 2720R, 2720L top are preferably applied to, to isolate adhesion layer 2720R, 2720L. Pharmaceutical preparation can be incorporated into substrate 2710R, 2710L structure.For bottom line, medicament can be at it from substrate Suppress the growth of undesirable organism in place of 2710R, 2710L contact tissue.Medicament can be from substrate 2710R, 2710L release simultaneously Migrate to wound or close to the region of wound.Medicament can be accommodated by carrier structures such as adhesion layer 2730R, 2730L, The carrier structure can absorb fluid and help the release of medicament.This class formation may include hydrocolloid, hydrophilic fibre (such as that A little hydrophilic fibres containing sodium carboxymethylcellulose), hydrogel, collagen, alginate, polyurethane foam or silicone bubble Foam or other associated materials as known in the art.Carrier can be alternatively or in combination ointment, emulsifiable paste, gel or powder. Pharmaceutical preparation (such as silver ion) can be put on alternatively or in combination via solvent coating process or gas deposition metal or Polymer (for example, metal or polymer of web form).Such netted product can combine or be embedded in the structure of closing device In.

In the exemplary embodiment, the pharmaceutical preparation comprising silver compounds such as silver sulfates can be incorporated into substrate In 2710R, 2710L.As substrate 2710R, 2710L are in contact with wound fluid and/or sweat or external fluid, Ke Yichao Medicament is transported to wound.As fluid is absorbed into substrate 2710R, 2710L, substrate 2710R, 2710L be able to can discharge Disturb the silver ion of bacterial growth.Illustrate how the medicaments such as silver can be incorporated into substrate in Figure 28 A- Figure 28 B Example, each embodiment of right substrate 2710R sample section 2750 in Figure 27 is shown in figure.These examples are also applicable to In left substrate 2710L.

Figure 27 B show pharmaceutical preparation 2760R, and it is mixed directly into the adhesion layer 2730R in sample section 2750.It is viscous Mixture is usually hydrocolloid, and it may can absorb the fluid for the notable percentage for accounting for its weight, so as to help the release of medicament.

Figure 27 C show another embodiment of right substrate 2710R sample section 2750, and pharmaceutical preparation is incorporated to wherein Into the carrier structure 2770R being incorporated on substrate 2710R, the part of the substrate 2710R close to otch I is preferably collected in On.Further feature can be incorporated to, so as to carrier structure 2770R by diffusate or other fluid institute's saturations and/or The concentration of pharmaceutical preparation peels (and replacing as needed) carrier structure 2770R off in the case of being brought down below level of significance.

Figure 27 D show the embodiment similar with Figure 27 C embodiment, wherein by the carrier knot comprising pharmaceutical preparation Structure 2770R is incorporated on substrate 2710R inward flange.

Figure 27 E illustrate how to be incorporated into carrier 2770R on substrate 2710R top and inward flange.At these In example, the carrier structure 2770R on substrate 2710R any inward flange or each inward flange can be pressed on wound or cut On mouth I, to help its stability on wound or otch I.

Pharmaceutical preparation and its carrier structure can be incorporated into the covering of cut closure apparatus alternatively or in combination.As above Literary described, covering is commonly used on the substrate of cut closure apparatus, to help apparatus being fastened to skin and protect skin. As depicted in fig. 28 a, covering 2800 can have to be incorporated into possess or do not possess carrier structure and (such as be mixed with pharmaceutical preparation Adhesion layer 2810) covering 2800 whole surface in pharmaceutical preparation 2810.Alternatively or in combination, medicament can be simultaneously Enter into the discrete parts of covering 2800, preferably in the carrier knot in wound location as shown in FIG. 28 B In structure 2820.

In at least some cases, carrier structure 2820 may become saturation and/or lose its medicine over time Intensity, and replace medicines structure 2820 would is that it is beneficial.As shown in Figure 28 C, medicines structure 2820 can be removable (for example, by tearing the perforation 2830 in covering 2800), and alternatively by coupled to the narrow covering shown in Figure 28 D Another medicines structure 2821 of band 2801 is replaced.In narrow covering tape 2801, the adhesive portion of covering 2801 can Medicines structure 2821 is extended beyond, with holding structure 2821 against skin.Narrow strips 2801 alternatively can apply covering Wound location is applied to before 2800.Covering 2800 can be designed to cover narrow strips 2801, or can have perforation 2830 to allow the removal of following band.

For any or whole two substrates 2710R, 2710L and covering 2800, carrier structure 2770R or 2820 (with or without pharmaceutical preparation) or individually pharmaceutical preparation can the patterns with the adhesion layer of respective structure.Band pattern Construction can include the repetition shape (for example, circle, ellipse, polygon, groove etc.) of adhesive material, the repetition shape is with carrying The similar repetition shape (or remainder of its matrix) of body structure is adjacent.This will may consequently contribute to ensure substrate 2710R, 2710L or covering 2800 adhesion, and pharmaceutical preparation is integrated in carrier structure 2770R or 2820 simultaneously.Show in Figure 28 E A simple examples are gone out, carrier structure 2820 includes repetition shape 2850 wherein.Pharmaceutical preparation and carrier structure 2820 are also It can be applied to the base portion band 2740 across otch I.

Although the preferred embodiment of the present invention has been illustrated and described herein, for those skilled in the art it is aobvious and It is clear to, such embodiment is only through way of example offer.Those skilled in the art can be without departing from the present invention's In the case of many changes may be made, change and replace.It should be appreciated that can use for as described herein in the practice of the invention The various replacements of embodiment of the present invention.Appended claims are intended to limit the scope of the present invention, and therefore cover these rights Method and structure and its equivalent in claimed range.

Claims

1. a kind of cut closure equipment, including：

First substrate, it is used for the first side for adhering to otch or wound, and the first substrate includes upper surface and tissue adhension Lower surface；

Second substrate, it is used for second side relative with first side for adhering to the otch or wound, second base Plate includes upper surface and tissue adhension lower surface；And

Multiple sway braces, it is coupled to each other by the first substrate and the second substrate,

Wherein described first substrate and the second substrate are axially stretchable and each included along its distribution of lengths One in multiple regions preferentially separated, the multiple region promotion first substrate preferentially separated or the second substrate Individual or multiple axially or transversally one or more of stretching or separation.

2. cut closure equipment as claimed in claim 1, wherein, the region preferentially separated is included through first base One or more perforation of plate or the second substrate.

3. cut closure equipment as claimed in claim 1, wherein, in one or more of perforation it is at least some along across The x wire placement of the first substrate or the second substrate.

4. cut closure equipment as claimed in claim 1, wherein, the multiple region preferentially separated allows first base Plate and the second substrate tear or are separated into multiple substrate sections in axial tension.

5. cut closure equipment as claimed in claim 1, wherein, at least some edges in the multiple region preferentially separated The transverse edge positioning of the first substrate or the second substrate, so as in following skin from the otch or wound footpath To reducing stress when stretching out.

6. cut closure equipment as claimed in claim 1, include more than first of upper surface coupled to the first substrate Individual axially-spaced support member and more than second axially-spaced support members of upper surface coupled to the second substrate.

7. cut closure equipment as claimed in claim 6, wherein, more than described first axially-spaced support member or described the One or more of individual support member being spaced laterally apart includes power distributed architecture more than two.

8. cut closure equipment as claimed in claim 6, wherein at least some by axial direction in the region preferentially separated It is placed between the axially adjacent support member on the first substrate or the second substrate.

9. cut closure equipment as claimed in claim 6, wherein more than described first axially-spaced support member or described the The support member of one or more of axially-spaced support member more than two is correspondingly positioned to and the first substrate or described the The inward flange of two substrates is axially adjacent.

10. cut closure equipment as claimed in claim 6, wherein the support member includes flexible not expandable material.

11. cut closure equipment as claimed in claim 6, wherein the support member be embedded in the upper surface of each plate or It is laminated to the upper surface of each plate.

12. cut closure equipment as claimed in claim 6, wherein one or more of described support member is C-shaped.

13. cut closure equipment as claimed in claim 1, wherein the multiple sway brace by the first substrate with it is described Second substrate is coupled reversibly and adjustably each other, to cause the interval between the first substrate and the second substrate to be It is adjustable.

14. cut closure equipment as claimed in claim 13, wherein the sway brace, which each has, is fixed to described first One end of one of substrate or the second substrate and the end relatively of one being adjustably attached in opposing substrate End, so as to allow the sway brace to be pulled together the first substrate with the second substrate, is cut to compress by described Wound or otch that mouth closure equipment is covered.

15. cut closure equipment as claimed in claim 14, wherein the opposing end portions of each sway brace are releasedly attached To lock, and wherein described sway brace and the lock form a ratch tensioning mechanism together.

16. cut closure equipment as claimed in claim 1, wherein one in the first substrate or the second substrate or It is multiple including elastic matrix.

17. cut closure equipment as claimed in claim 16, wherein the elastic matrix include elastomer film, Woven fabric, Short fibre fabric, rubber, latex, urethane, polyurethane, silicone or thermoplastic elastomer (TPE) (TPE).

18. cut closure equipment as claimed in claim 17, wherein the elastic matrix includes fabric, the fabric is by elasticity Element weave and with along one or more of the first substrate or the second substrate transverse edge and across The inelastic component extended laterally therebetween.

19. cut closure equipment as claimed in claim 1, wherein one in the first substrate or the second substrate or Multiple tissue adhension lower surfaces includes hydrophily adhesion material.

20. cut closure equipment as claimed in claim 19, wherein the hydrophily adhesion material includes hydrocolloid, water-setting One or more in glue, acrylate copolymer or PEG.

21. cut closure equipment as claimed in claim 1, in addition to fastened layer, the fastened layer are suitable in first base After the assembly of plate and the second substrate and the sway brace has been anchored on the otch or wound, institute is placed on State on assembly.

22. cut closure equipment as claimed in claim 21, wherein the fastened layer has self-adhering type inner surface.

23. cut closure equipment as claimed in claim 21, wherein the fastened layer is arranged to extend laterally beyond institute State the outer transverse edge of first substrate or the second substrate.

24. cut closure equipment as claimed in claim 21, wherein the fastened layer has and one or more preferentially separated Region, one or more of regions preferentially separated allow the fastened layer in response to the otch or wound and surrounding group The axial tension knitted and axial tension at least in part, wherein the cut closure equipment is positioned in the surrounding tissue.